Early and locally advanced

breast cancer: diagnosis

and management

NICE guideline
Published: 18 July 2018
Last updated: 14 June 2023

www.nice.org.uk/guidance/ng101

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conditions#notice-of-rights).
Early and locally advanced breast cancer: diagnosis and management (NG101)

Your responsibility
The recommendations in this guideline represent the view of NICE, arrived at after careful
consideration of the evidence available. When exercising their judgement, professionals
and practitioners are expected to take this guideline fully into account, alongside the
individual needs, preferences and values of their patients or the people using their service.
It is not mandatory to apply the recommendations, and the guideline does not override the
responsibility to make decisions appropriate to the circumstances of the individual, in
consultation with them and their families and carers or guardian.

All problems (adverse events) related to a medicine or medical device used for treatment
or in a procedure should be reported to the Medicines and Healthcare products Regulatory
Agency using the Yellow Card Scheme.

Local commissioners and providers of healthcare have a responsibility to enable the

guideline to be applied when individual professionals and people using services wish to
use it. They should do so in the context of local and national priorities for funding and
developing services, and in light of their duties to have due regard to the need to eliminate
unlawful discrimination, to advance equality of opportunity and to reduce health
inequalities. Nothing in this guideline should be interpreted in a way that would be
inconsistent with complying with those duties.

Commissioners and providers have a responsibility to promote an environmentally

sustainable health and care system and should assess and reduce the environmental
impact of implementing NICE recommendations wherever possible.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Contents
Overview ...................................................................................................................................... 6

Who is it for? ........................................................................................................................................... 6

Recommendations ....................................................................................................................... 7

1.1 Preoperative assessment ................................................................................................................. 7

1.2 Providing information and psychological support ......................................................................... 8

1.3 Surgery to the breast ....................................................................................................................... 9

1.4 Surgery to the axilla ......................................................................................................................... 10

1.5 Breast reconstruction ....................................................................................................................... 12

1.6 Diagnostic assessment and adjuvant therapy planning ............................................................... 16

1.7 Endocrine therapy ............................................................................................................................ 18

1.8 Adjuvant chemotherapy for invasive breast cancer ..................................................................... 24

1.9 Bisphosphonate therapy .................................................................................................................. 28

1.10 Radiotherapy ................................................................................................................................... 29

1.11 Primary systemic therapy ............................................................................................................... 35

1.12 Complications of local treatment and menopausal symptoms................................................... 41

1.13 Follow-up ......................................................................................................................................... 45

1.14 Lifestyle............................................................................................................................................ 46

Terms used in this guideline.................................................................................................................. 47

Recommendations for research ................................................................................................. 48

1 Surgery to the breast .......................................................................................................................... 48

2 Adjuvant bisphosphonate therapy .................................................................................................... 48

3 Breast reconstruction ......................................................................................................................... 48

4 Neoadjuvant endocrine therapy in premenopausal women ........................................................... 49

5 Neoadjuvant endocrine therapy in postmenopausal women ......................................................... 49

6 Neoadjuvant treatment ...................................................................................................................... 50

7 Strategies to reduce arm and shoulder problems ........................................................................... 50

8 Adherence and satisfaction for interventions to reduce arm and shoulder problems ................. 50

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Early and locally advanced breast cancer: diagnosis and management (NG101)

9 Effectiveness of 26 Gy in 5 fractions over 1 week regimen in people receiving breast

reconstruction ........................................................................................................................................ 51

10 Effectiveness of 26 Gy in 5 fractions over 1 week regimen in people receiving nodal

irradiation ................................................................................................................................................ 52

Rationale and impact................................................................................................................... 53

Providing information and psychological support............................................................................... 53

Surgery to the breast ............................................................................................................................. 53

Evaluation and management of a positive axillary lymph node ......................................................... 54

Breast reconstruction ............................................................................................................................ 55

Predictive factors ................................................................................................................................... 56

Adjuvant therapy planning .................................................................................................................... 57

Ovarian function suppression ............................................................................................................... 58

Extended endocrine therapy ................................................................................................................. 59

Endocrine therapy for ductal carcinoma in situ................................................................................... 60

Adjuvant chemotherapy for invasive breast cancer ........................................................................... 60

Biological therapy ................................................................................................................................... 61

Adjuvant bisphosphonate therapy ....................................................................................................... 62

Radiotherapy techniques....................................................................................................................... 63

Radiotherapy after breast-conserving surgery ................................................................................... 64

Radiotherapy after mastectomy ........................................................................................................... 65

Dose fractionation of external beam radiotherapy ............................................................................. 66

Radiotherapy to nodal areas ................................................................................................................. 69

Neoadjuvant chemotherapy .................................................................................................................. 69

Neoadjuvant chemotherapy regimens ................................................................................................. 70

Neoadjuvant endocrine therapy ........................................................................................................... 71

Radiotherapy after neoadjuvant chemotherapy ................................................................................. 71

Lymphoedema ........................................................................................................................................ 72

Arm and shoulder mobility .................................................................................................................... 73

Lifestyle ................................................................................................................................................... 76

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Context ......................................................................................................................................... 78

Groups that are covered ........................................................................................................................ 79

Groups that are not covered ................................................................................................................. 79

Finding more information and committee details ..................................................................... 80

Update information ..................................................................................................................... 81

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Early and locally advanced breast cancer: diagnosis and management (NG101)

This guideline replaces CG80, TA107, TA108, TA109, TA112 and ES15.

This guideline is the basis of QS12.

Overview
This guideline covers diagnosing and managing early and locally advanced breast cancer.
It aims to help healthcare professionals offer the right treatments to people, taking into
account the person's individual preferences.

NICE have also produced guidelines on advanced breast cancer, familial breast cancer and
suspected cancer: recognition and referral.

Who is it for?
• Healthcare professionals

• Commissioners and providers of breast cancer services

• People with early and locally advanced breast cancer, their families and carers

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Recommendations
People have the right to be involved in discussions and make informed decisions
about their care, as described in NICE's information on making decisions about your
care.

This guideline uses specific, inclusive language to describe the population groups it
covers (for example, women and pregnant people, or trans and non-binary people)
except when:

• the evidence for the recommendation has not been reviewed and it is not certain
from expert opinion whether it can cover more groups, or

• the evidence has been reviewed, but the information available for some groups at
the time of development was too limited to make specific recommendations, or

• only a very limited number of recommendations have been updated in direct

response to new evidence or to reflect a change in practice.

Healthcare professionals should use their clinical judgement when implementing

gender-specific recommendations, taking into account the individual's
circumstances, needs and preferences, and ensuring all people are treated with
dignity and respect throughout their care.

Making decisions using NICE guidelines explains how we use words to show the
strength (or certainty) of our recommendations, and has information about
prescribing medicines (including off-label use), professional guidelines, standards
and laws (including on consent and mental capacity), and safeguarding.

1.1 Preoperative assessment

1.1.1 For people having investigations for early and locally advanced invasive
breast cancer:

• perform pretreatment ultrasound evaluation of the axilla, and

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Early and locally advanced breast cancer: diagnosis and management (NG101)

• if abnormal lymph nodes are identified, perform ultrasound-guided needle

sampling. [2009]

1.1.2 Do not routinely use MRI of the breast as part of the preoperative
assessment of people with biopsy-proven invasive breast cancer or
ductal carcinoma in situ (DCIS). [2009]

1.1.3 Offer MRI of the breast as part of preoperative assessment to people

with invasive breast cancer:

• if the extent of disease is not clear from clinical examination, mammography

and ultrasound assessment for planning treatment

• if accurate mammographic assessment is difficult because of breast density

• to assess the tumour size if breast-conserving surgery is being considered for

invasive lobular cancer. [2009]

Genetic testing
1.1.4 Offer genetic testing for BRCA1 and BRCA2 mutations to women under
50 years with triple-negative breast cancer, including those with no
family history of breast or ovarian cancer (also see the recommendations
on genetic testing in the NICE guideline on familial breast cancer). [2017]

1.2Providing information and psychological

support
1.2.1 Ensure all people with breast cancer have a named clinical nurse
specialist, or other specialist key worker with equivalent skills, to support
them throughout diagnosis, treatment and follow-up. [2009, amended
2018]

1.2.2 Offer all people with breast cancer prompt access to specialist
psychological support and, where appropriate, psychiatric services.
[2009]

1.2.3 Discuss opportunities for people with breast cancer to be involved in

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Early and locally advanced breast cancer: diagnosis and management (NG101)

research, and encourage entry into clinical trials and other studies.
[2018]

1.2.4 For guidance on fertility preservation, see the recommendations on

people with cancer who wish to preserve fertility in the NICE guideline on
fertility problems. [2018]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on providing
information and psychological support.

1.3 Surgery to the breast

1.3.1 Offer further surgery (re-excision or mastectomy, as appropriate) after
breast-conserving surgery where invasive cancer or DCIS is present at
the radial margins ('tumour on ink'; 0 mm). [2018]

1.3.2 For women who have had breast-conserving surgery where invasive
cancer or DCIS is present within 2 mm of, but not at, the radial margins
(greater than 0 mm and less than 2 mm):

• discuss the benefits and risks of further surgery (re-excision or mastectomy) to

minimise the risk of local recurrence

• take into account the woman's preferences, comorbidities, tumour

characteristics and the potential use of radiotherapy (also see radiotherapy
after breast-conserving surgery). [2018]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on surgery to the
breast.

Full details of the evidence and the committee's discussion are in evidence review A:
surgery to the breast.

1.3.3 All breast units should audit their recurrence rates after treatment.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

[2009, amended 2018]

Paget's disease
1.3.4 Offer breast-conserving surgery with removal of the nipple–areolar
complex as an alternative to mastectomy for people with Paget's disease
of the nipple that has been assessed as localised. Offer oncoplastic
repair techniques to maximise cosmesis. [2009]

1.4 Surgery to the axilla

Invasive breast cancer

1.4.1 Perform surgery using sentinel lymph node biopsy (SLNB) rather than
axillary lymph node clearance to stage the axilla for people with invasive
breast cancer if they have:

• no evidence of lymph node involvement on ultrasound, or

• a negative ultrasound-guided needle biopsy. [2009, amended 2023]

1.4.2 Perform SLNB using the dual technique with isotope and blue dye.
[2009]

1.4.3 Breast units should audit their axillary recurrence rates. [2009]

Ductal carcinoma in situ

1.4.4 Do not routinely perform SLNB for women with a preoperative diagnosis
of DCIS who are having breast-conserving surgery, unless they are
considered to be at high risk of invasive disease. People at high risk of
invasive disease include those with a palpable mass or extensive
microcalcifications. [2009]

1.4.5 Offer SLNB to all people who are having a mastectomy for DCIS. [2009]

Evaluation and management of a positive axillary lymph node

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Early and locally advanced breast cancer: diagnosis and management (NG101)

identified by a preoperative ultrasound-guided needle biopsy

1.4.6 Offer axillary node clearance to people with invasive breast cancer who
have a preoperative ultrasound-guided needle biopsy with pathologically
proven lymph node metastases. [2009, amended 2018]

Evaluation and management of a positive axillary lymph node

identified by a sentinel lymph node biopsy (in people with a
normal preoperative ultrasound-guided needle biopsy)
1.4.7 Offer further axillary treatment (axillary node clearance or radiotherapy)
after SLNB to people who have 1 or more sentinel lymph node
macrometastasis. [2018]

1.4.8 Discuss the benefits and risks of not having further axillary treatment
after primary breast-conserving surgery (within clinical trials where
available) with women who:

• have 1 or 2 sentinel lymph node macrometastases and

• have been advised to have whole-breast radiotherapy with systemic therapy

(which may be endocrine therapy). [2018]

1.4.9 Do not offer further axillary treatment to people who only have
micrometastases in their sentinel lymph nodes after primary surgery for
invasive breast cancer. [2018]

1.4.10 Do not offer further axillary treatment to people who have isolated
tumour cells in their sentinel lymph nodes after primary surgery for
invasive breast cancer. Classify this as lymph node-negative breast
cancer. [2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on evaluation
and management of a positive axillary lymph node.

Full details of the evidence and the committee's discussion are in evidence review B:
management of the positive axilla.

1.5 Breast reconstruction

1.5.1 Offer breast reconstruction to people after they have had mastectomy
for breast cancer. [2023]

1.5.2 Be aware that some people may prefer not to have breast reconstruction
surgery. [2018]

1.5.3 Offer both breast reconstruction options to women (immediate

reconstruction and delayed reconstruction), whether or not they are
available locally. [2018]

1.5.4 Offer immediate breast reconstruction to women who have been advised
to have a mastectomy, including those who may need radiotherapy,
unless they have comorbidities that rule out reconstructive surgery.
[2018, amended 2023]

1.5.5 Discuss the benefits and risks of immediate breast reconstruction and
delayed breast reconstruction with women. Topics to discuss include
those in table 1 and:

• the timing of breast reconstruction surgery (at the same time as mastectomy or
later)

• different breast reconstruction surgery options and what they involve

• how the timing of breast reconstruction surgery affects the options available

• the uncertainty over long-term outcomes in women having radiotherapy.

[2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Table 1 Breast reconstruction options for women who choose breast reconstruction

Category Immediate breast reconstruction Delayed breast reconstruction

Reconstruction is started in the After a mastectomy,

Definition same operation as the reconstruction is done in a
mastectomy separate operation

More than 1 operation is usually More than 1 operation is usually

needed to complete the needed to complete the
reconstruction reconstruction
The total number of operations will The total number of operations will
vary. It may be affected by factors vary. It may be affected by factors
such as: such as:

Number and • type of reconstruction (for • type of reconstruction (for

timing of example, some are planned in example, some are planned in
operations stages; a prosthesis may be stages; a prosthesis may be
worn until reconstruction is worn until reconstruction is
complete) complete)

• personal preferences (such as • personal preferences (such as

whether a nipple reconstruction whether a nipple reconstruction
is requested) is requested)

Fewer operations may be needed More operations may be needed

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Category Immediate breast reconstruction Delayed breast reconstruction

These will vary depending on

These will vary depending on
personal preferences (such as
personal preferences (such as
breast size desired), current body
breast size desired), current body
shape, other health conditions,
shape, other health conditions,
previous operations and lifestyle
previous operations and lifestyle
factors (such as hobbies)
factors (such as hobbies)
Not all hospitals or surgeons can
Not all hospitals or surgeons can
Breast offer all procedures. Travel to a
offer all procedures. Travel to a
reconstruction different hospital may be needed
different hospital may be needed
options for a specific option
for a specific option
available Options may be available that
Certain options that spare or
spare or preserve the breast skin
preserve the breast skin may not
(which may mean less scarring
be available
and a more natural look)
More time to make a decision
Limited time to make a decision
(which may include not having a
about options (which may include
reconstruction) and to plan
not having a reconstruction)
reconstruction
before surgery

Lifestyle changes (such as losing

weight and taking regular
Breast shape remains, which may exercise) may be possible, which
help maintain body image and increase the options and lower the
Benefits
have subsequent psychological risks of reconstruction surgery
benefits Procedures (and associated
recovery) can be planned around
other commitments

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Category Immediate breast reconstruction Delayed breast reconstruction

Surgical complications can occur

Surgical complications can occur
after any breast reconstruction
after any breast reconstruction
and will vary by type of procedure
and will vary by type of procedure
and personal risk factors
and personal risk factors
May be lower rates of:
May be lower rates of:
• tissue breakdown
• mastectomy site complications
• surgery for flap removal if it
• flap or implant failure (which
cannot be used because of a
may lead to delayed
complication (which may lead
Risks reconstruction and flat
to delayed reconstruction and
appearance for a period of
flat appearance for a period of
time)
time)
• capsular contracture (a scar
• procedures to improve
layer around the implant that
symmetry
may lead to pain if severe)
Complications from the
May need to interrupt hormone
mastectomy or axillary surgery
therapies (tamoxifen) for further
can occur during the recovery
surgery
period

No clear differences in satisfaction No clear differences in satisfaction

Satisfaction
with completed reconstructions with completed reconstructions

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Category Immediate breast reconstruction Delayed breast reconstruction

Radiotherapy or chemotherapy
can be given but may be delayed if
there are complications from the
Reconstruction mastectomy or reconstruction
and adjuvant Immediate reconstructions using
Complications can also occur after
therapy implants may be more affected by
mastectomy alone, which may
(including radiotherapy than immediate flap
delay chemotherapy or
radiotherapy reconstructions
radiotherapy
and May need adaptions to scans if a
chemotherapy) tissue expander is used. For
example, may not be able to have
MRI scans and may need modified
radiotherapy planning

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on breast
reconstruction.

Full details of the evidence and the committee's discussion are in evidence review I:
postmastectomy radiotherapy.

1.6 Diagnostic assessment and adjuvant therapy

planning

Predictive factors
1.6.1 Assess the oestrogen receptor (ER), progesterone receptor (PR) and
human epidermal growth factor receptor 2 (HER2) status of all invasive
breast cancers simultaneously at the time of initial histopathological
diagnosis. [2018]

1.6.2 Assess the ER status of all invasive breast cancers using standardised
and quality-assured immunohistochemical techniques, and report the

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Early and locally advanced breast cancer: diagnosis and management (NG101)

results quantitatively. [2009]

1.6.3 Assess the PR status of all invasive breast cancers using standardised
and quality-assured immunohistochemical techniques, and report the
results quantitatively. [2018]

1.6.4 Assess the HER2 status of all invasive breast cancers using standardised
and quality-assured techniques, and report the results quantitatively.
[2009]

1.6.5 Ensure that the ER, PR and HER2 statuses are available and recorded at
the preoperative and postoperative multidisciplinary team meetings
when systemic treatment is discussed. [2018]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on predictive
factors.

Full details of the evidence and the committee's discussion are in evidence review C:
adjuvant systemic therapy planning.

Adjuvant therapy planning

1.6.6 Consider adjuvant therapy after surgery for people with invasive breast
cancer, and ensure that recommendations are documented at the
multidisciplinary team meeting. [2009]

1.6.7 Base recommendations about adjuvant therapy on multidisciplinary team

assessment of the prognostic and predictive factors, and the possible
risks and benefits of the treatment. Make decisions with the person after
discussing these factors. [2009, amended 2018]

1.6.8 Use the PREDICT tool to estimate prognosis and the absolute benefits of
adjuvant therapy for women with invasive breast cancer. [2018]

1.6.9 When using the PREDICT tool, be aware that:

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Early and locally advanced breast cancer: diagnosis and management (NG101)

• it is less accurate for:

－ women under 30 with ER-positive breast cancer

－ women aged 70 and over

－ women with tumours larger than 50 mm

• it has not been validated in men, and

• the validation may have under-represented some ethnic groups.

Take into account that the potential limitations in versions of PREDICT after 2.0
may differ from those listed here (also see the PREDICT tool frequently asked
questions). [2018, amended 2023]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on adjuvant
therapy planning.

Full details of the evidence and the committee's discussion are in evidence review C:
adjuvant systemic therapy planning.

Tumour profiling tests to guide adjuvant chemotherapy decisions

The NICE diagnostics guidance on tumour profiling tests provides evidence-based
recommendations on tumour profiling tests to guide adjuvant chemotherapy decisions.

1.7 Endocrine therapy

1.7.1 Treat all people with invasive breast cancer with surgery and appropriate
systemic therapy, rather than endocrine therapy alone, unless a
significant comorbidity means surgery is not suitable for them. [2009]

Adjuvant endocrine therapy for invasive breast cancer

1.7.2 Offer tamoxifen as the initial adjuvant endocrine therapy for men and
premenopausal women with ER-positive invasive breast cancer. [2009,

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amended 2018]

1.7.3 Offer an aromatase inhibitor as the initial adjuvant endocrine therapy for
postmenopausal women with ER-positive invasive breast cancer who are
at medium or high risk of disease recurrence. Offer tamoxifen to women
who are at low risk of disease recurrence, or if aromatase inhibitors are
not tolerated or are contraindicated. [2009, amended 2018]

Ovarian function suppression

1.7.4 Consider ovarian function suppression in addition to endocrine therapy
for premenopausal women with ER-positive invasive breast cancer.
[2018]

1.7.5 Discuss the benefits and risks of ovarian function suppression in addition
to endocrine therapy with premenopausal women with ER-positive
invasive breast cancer. Explain to women that ovarian function
suppression may be most beneficial for those women who are at
sufficient risk of disease recurrence to have been offered chemotherapy.
[2018]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on ovarian
function suppression.

Full details of the evidence and the committee's discussion are in evidence review D:
endocrine therapy for invasive disease.

Extended endocrine (hormone) therapy

In June 2023, the use of aromatase inhibitors in recommendations 1.7.6 and 1.7.7 was
off-label. See NICE's information on prescribing medicines.

1.7.6 Discuss the benefits and risks of extended endocrine therapy with
people who this treatment may be suitable for (see table 2). [2018,

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amended 2023]

1.7.7 Offer extended endocrine therapy (past the 5-year point) with an
aromatase inhibitor for postmenopausal women with ER-positive invasive
breast cancer who are at medium or high risk of disease recurrence and
who have been taking tamoxifen for 2 to 5 years. Medium or high risk
may include people who have lymph node-positive breast cancer, with
tumours that are T2 or greater and higher grade. [2018]

1.7.8 Consider extended endocrine therapy (past the 5-year point) with an
aromatase inhibitor for postmenopausal women with ER-positive invasive
breast cancer who are at low risk of disease recurrence and who have
been taking tamoxifen for 2 to 5 years. Low risk may include people with
lymph node-negative breast cancer, with smaller or lower-grade
tumours. [2018]

1.7.9 Consider extending the duration of tamoxifen therapy for longer than
5 years for people with ER-positive invasive breast cancer. [2018]

Table 2 Effects of extended endocrine therapy

Extended
endocrine therapy
Extended tamoxifen therapy with an aromatase
Category (after an initial 5 years of inhibitor (after
tamoxifen therapy) 5 years of
tamoxifen
therapy)

Switching to an
Continuing to take tamoxifen aromatase
Definition after 5 years of tamoxifen inhibitor after
therapy 5 years of
tamoxifen therapy

Postmenopausal
People with ER-positive women with ER-
Who can take this therapy
invasive breast cancer positive invasive
breast cancer

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Extended
endocrine therapy
Extended tamoxifen therapy with an aromatase
Category (after an initial 5 years of inhibitor (after
tamoxifen therapy) 5 years of
tamoxifen
therapy)

Effect on breast cancer

Lower rates of
recurrence:
breast cancer
The benefit for an individual
recurrence
person will depend on the risk of
compared with
their cancer returning. For people
5 years of
with a low risk of recurrence, the
tamoxifen therapy
benefits may not outweigh the Evidence shows lower rates of
In postmenopausal
risks or side effects breast cancer recurrence
women, switching
Medium or high risk may include compared with 5 years of
to an aromatase
people who have lymph node- tamoxifen therapy in women
inhibitor may be
positive breast cancer, with
more effective at
tumours that are T2 or greater
reducing
and higher grade. Low risk may
recurrence than
include people with lymph node-
continuing with
negative breast cancer, with
tamoxifen
smaller or lower-grade tumours

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Extended
endocrine therapy
Extended tamoxifen therapy with an aromatase
Category (after an initial 5 years of inhibitor (after
tamoxifen therapy) 5 years of
tamoxifen
therapy)

Side effects of
Side effects of endocrine endocrine therapy
therapy will continue for will continue for
additional years (for example, additional years
Side effects: menopausal symptoms such as (for example,
These are common side effects hot flushes) menopausal
experienced during additional Side effects may differ in men symptoms such as
years taking endocrine therapy. With extended use of hot flushes)
Most effects are reversible when tamoxifen: increased risk of With extended use
tablets are stopped thrombosis and endometrial of aromatase
cancer, and possibly bone inhibitors: bone
density loss in premenopausal density loss, and
women joint and muscle
pain

For women, effects on fertility

and family planning will
continue for additional years as
they should not become Not applicable as
Fertility and family planning pregnant while taking postmenopausal
tamoxifen, or within 2 months women only
of stopping, because it may
have adverse effects on the
baby

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For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on extended
endocrine therapy.

Full details of the evidence and the committee's discussion are in evidence review D:
endocrine therapy for invasive disease.

Endocrine therapy for ductal carcinoma in situ

1.7.10 Discuss the benefits and risks (see table 3) of endocrine therapy after
breast-conserving surgery for women with ER-positive DCIS. [2018]

1.7.11 Offer endocrine therapy after breast-conserving surgery for women with
ER-positive DCIS if radiotherapy is recommended but not received.
[2018]

1.7.12 Consider endocrine therapy after breast-conserving surgery for women

with ER-positive DCIS if radiotherapy is not recommended. [2018]

Table 3 Effects of endocrine therapy after breast-conserving surgery for women with
ER-positive DCIS

Endocrine therapy after breast-conserving

Category
surgery for women with ER-positive DCIS

Tamoxifen or an aromatase inhibitor for

Definition
5 years, taken as a once-daily tablet

Effect on survival and disease recurrence:

The benefit for an individual person will No effect on survival at 5 or 10 years after
depend on the risk of their cancer diagnosis
returning. For people with low risk of Lower rate of recurrence of DCIS and lower
recurrence, the benefits may not outweigh rate of invasive breast cancer, compared
the risks or side effects with women who did not receive endocrine
Risk can be estimated using a range of therapy or radiotherapy after surgery
standardised tools and clinical expertise

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Endocrine therapy after breast-conserving

Category
surgery for women with ER-positive DCIS

All endocrine therapies: menopausal

symptoms, such as hot flushes
For tamoxifen: increased risk of thrombosis,
endometrial cancer and possibly bone
Side effects
density loss in premenopausal women
For aromatase inhibitors: joint and muscle
pain, urogenital symptoms and bone
density loss

Effects on fertility and family planning as

women should not become pregnant while
Fertility and family planning taking tamoxifen, or within 2 months of
stopping, because it may have adverse
effects on the baby

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on endocrine
therapy for DCIS.

Full details of the evidence and the committee's discussion are in evidence review D:
endocrine therapy for invasive disease.

1.8 Adjuvant chemotherapy for invasive breast

cancer
1.8.1 For people with breast cancer where chemotherapy is indicated, offer a
regimen that contains both a taxane and an anthracycline. Refer to the
summaries of product characteristics for individual taxanes and
anthracyclines to check for differences in licensed indications. [2018,
amended 2023]

1.8.2 Discuss with people the benefits and risks of adding a taxane to
anthracycline-containing regimens. Topics to discuss include those in

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Early and locally advanced breast cancer: diagnosis and management (NG101)

table 4 and:

• the benefits of reduced cardiac toxicity and reduced nausea

• the risks of additional side effects, including neuropathy, neutropenia and

hypersensitivity

• the different side effects and dosing frequencies of different docetaxel and
paclitaxel regimens, and the additional clinic visits that may be needed

• that absolute benefit is proportional to absolute risk of recurrence

Refer to the summaries of product characteristics for individual taxanes and

anthracyclines to check for differences in licensed indications. [2018]

Table 4 Benefits and risks of adding a taxane to anthracycline-containing regimens and

comparison of different taxane regimens [2018, amended 2023]

Effect of adding a taxane to an

Weekly or fortnightly
anthracycline-containing 3-weekly docetaxel
paclitaxel
regimen

Effect on survival:
The benefit for an individual Some evidence for Some evidence for
person will depend on the risk improved outcomes, improved outcomes,
of their cancer returning. For including reducing the including reducing the risk
people with low risk of risk of breast cancer of breast cancer returning
recurrence, the benefits may returning and increasing and increasing the chance
not outweigh the risks or side the chance of surviving of surviving
effects

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Effect of adding a taxane to an

Weekly or fortnightly
anthracycline-containing 3-weekly docetaxel
paclitaxel
regimen

Smaller doses of Smaller doses of

anthracyclines can be anthracyclines can be
used, which can reduce used, which can reduce
the risk of side effects the risk of side effects
such as nausea and such as nausea and
vomiting vomiting
Benefits
Smaller cumulative doses Smaller cumulative doses
of individual drugs may of individual drugs may
reduce long-term side reduce long-term side
effects, for example, effects, for example,
cardiac toxicity and risk cardiac toxicity and risk of
of second malignancies second malignancies

Additional side effects

may include nerve
damage and
Additional side effects hypersensitivity reactions,
may include joint and but febrile neutropenia is
muscle pain, nerve less likely than with
damage, higher rates of 3-weekly docetaxel
febrile neutropenia and Some people have long-
Side effects
hypersensitivity reactions term hair loss (alopecia)
Some people have long- after treatment with
term hair loss (alopecia) taxanes
after treatment with Weekly paclitaxel is
taxanes tolerated best, but even
fortnightly is better
tolerated than 3-weekly
docetaxel

Visits to hospital every Visits to hospital every

Administration
3 weeks week or every 2 weeks

9 to 12 weeks (3 to
Length of course 8 to 12 weeks
4 cycles)

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Early and locally advanced breast cancer: diagnosis and management (NG101)

1.8.3 Ensure weekly and fortnightly paclitaxel is available locally, as it is better

tolerated than 3-weekly docetaxel, particularly in people with
comorbidities. [2018, amended 2023]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on adjuvant
chemotherapy for invasive breast cancer.

Full details of the evidence and the committee's discussion are in evidence review E:
adjuvant chemotherapy.

Biological therapy
1.8.4 Offer adjuvant trastuzumab for people with T1c and above HER2-positive
invasive breast cancer. Give this at 3-week intervals for 1 year in
combination with surgery, chemotherapy, endocrine therapy and
radiotherapy, as appropriate. [2009, amended 2023]

1.8.5 Consider adjuvant trastuzumab for people with T1a/T1b HER2-positive

invasive breast cancer, taking into account any comorbidities, prognostic
features, possible toxicity of chemotherapy and the person's
preferences. [2018]

For a short explanation of why the committee made the 2018 recommendation and
how it might affect practice, see the rationale and impact section on biological
therapy.

Full details of the evidence and the committee's discussion are in evidence review F:
adjuvant biological therapy.

1.8.6 Use trastuzumab with caution in people with HER2-positive invasive

breast cancer if they have any of the following:

• a baseline left ventricular ejection fraction (LVEF) of 55% or less

• a history of, or current, congestive heart failure

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Early and locally advanced breast cancer: diagnosis and management (NG101)

• a history of myocardial infarction

• angina pectoris needing medication

• cardiomyopathy

• cardiac arrhythmias needing medical treatment

• clinically significant valvular heart disease

• haemodynamic-effective pericardial effusion

• poorly controlled hypertension. [2009, amended 2018]

1.9 Bisphosphonate therapy

Adjuvant bisphosphonate therapy

In June 2023, the use of bisphosphonates (zoledronic acid or sodium clodronate) in

recommendations 1.9.1 and 1.9.2 was off-label. See NICE's information on prescribing
medicines.

1.9.1 Offer bisphosphonates (zoledronic acid or sodium clodronate) as

adjuvant therapy to postmenopausal women with node-positive invasive
breast cancer. [2018]

1.9.2 Consider bisphosphonates (zoledronic acid or sodium clodronate) as

adjuvant therapy for postmenopausal women with node-negative
invasive breast cancer and a high risk of recurrence. [2018]

1.9.3 Discuss the benefits and risks of bisphosphonate treatment with women,
particularly the risk of osteonecrosis of the jaw, atypical femoral
fractures and osteonecrosis of the external auditory canal. Follow the
Medicines and Healthcare products Regulatory Agency/Commission on
Human Medicines (MHRA/CHM) advice on bisphosphonates. [2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on adjuvant
bisphosphonate therapy.

Full details of the evidence and the committee's discussion are in evidence review G:
adjuvant bisphosphonates.

Bone health
1.9.4 Offer a baseline dual-energy X-ray absorptiometry (DEXA) scan to
assess bone mineral density in women with invasive breast cancer who
are not receiving bisphosphonates as adjuvant therapy and who:

• are starting adjuvant aromatase inhibitor treatment, or

• have treatment-induced menopause, or

• are starting ovarian ablation/suppression therapy. [2009, amended 2018]

1.9.5 Do not offer a DEXA scan to people with invasive breast cancer who are
receiving tamoxifen alone. [2009, amended 2023]

1.9.6 Offer bisphosphonates to women identified by algorithms 1 and 2 in the

guidance for the management of breast cancer treatment-induced bone
loss: a consensus position statement from a UK expert group (2008; this
guidance is not NICE accredited). [2009]

1.10 Radiotherapy
1.10.1 Use a radiotherapy technique that minimises the dose to the lung and
heart. [2018]

1.10.2 Use a deep inspiratory breath-hold radiotherapy technique for people

with left-sided breast cancer to reduce the dose to the heart. [2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on radiotherapy
techniques.

Full details of the evidence and the committee's discussion are in evidence review H:
breast radiotherapy.

Radiotherapy after breast-conserving surgery

1.10.3 Offer whole-breast radiotherapy to women with invasive breast cancer
who have had breast-conserving surgery with clear margins. [2018]

1.10.4 Consider partial-breast radiotherapy as an alternative to whole-breast

radiotherapy for women who have had breast-conserving surgery for
invasive cancer (excluding lobular type) with clear margins and who:

• have a low absolute risk of local recurrence (defined as women aged 50 and
over with tumours that are 3 cm or less, N0, ER-positive, HER2-negative and
grade 1 to 2), and

• have been advised to have adjuvant endocrine therapy for a minimum of

5 years. [2018]

1.10.5 If partial-breast radiotherapy (see recommendation 1.10.4) may be

suitable for a woman, discuss the benefits and risks with them and reach
a shared decision on its use. Topics to cover include that:

• local recurrence with partial-breast radiotherapy at 5 years is equivalent to that

with whole-breast radiotherapy

• the risk of local recurrence beyond 5 years is not yet known

• there is a potential reduction in late adverse effects. [2018, amended 2023]

1.10.6 When giving partial-breast radiotherapy, use external beam radiotherapy.

[2018]

1.10.7 Consider not using radiotherapy for women who:

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Early and locally advanced breast cancer: diagnosis and management (NG101)

• have had breast-conserving surgery for invasive breast cancer with clear
margins and

• have a very low absolute risk of local recurrence (defined as women aged
65 and over with tumours that are T1N0, ER-positive, HER2-negative and
grade 1 to 2) and

• are willing to take adjuvant endocrine therapy for a minimum of 5 years. [2018]

1.10.8 When considering not using radiotherapy (see recommendation 1.10.7),

discuss the benefits and risks with the woman (see table 5) and explain
that:

• without radiotherapy, local recurrence occurs in about 50 women per 1,000 at

5 years, and with radiotherapy, occurs in about 10 women per 1,000 at 5 years

• overall survival at 10 years is the same with or without radiotherapy

• there is no increase in serious late effects if radiotherapy is given (for example,

congestive cardiac failure, myocardial infarction or secondary cancer). [2018]

Table 5 Benefits and risks of radiotherapy compared with no radiotherapy in the low-
risk group described in recommendation 1.10.7

Category Radiotherapy No radiotherapy

On average, in 1,000
On average, in 1,000 women, over 5 years
women, over 5 years local
Effect on local local recurrence occurs in about 10
recurrence occurs in about
recurrence women, and does not occur in about 990
50 women, and does not
women
occur in about 950 women

Effect on No difference in overall

No difference in overall survival at 10 years
survival survival at 10 years

Possibility of short- and long-term adverse

No short- or long-term
effects on the breast, and resulting
adverse effects on the
Risks cosmetic changes (such as skin soreness,
breast, or cosmetic
changes to colour of skin, radiation fibrosis
changes
or stiffening of the breast tissue)

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Category Radiotherapy No radiotherapy

In this group of women at low risk, there is

no increase in serious late side effects of
No side effects of
Side effects radiotherapy (such as congestive cardiac
radiotherapy will occur
failure, myocardial infarction or secondary
cancer)

No need to attend the

Given at the treatment centre 5 days a
Administration treatment centre for
week for 3 weeks after surgery
radiotherapy sessions

1.10.9 Consider adjuvant radiotherapy for women with DCIS following breast-
conserving surgery with clear margins. Discuss the possible benefits and
risks of radiotherapy (also see the section on surgery to the breast) and
make a shared decision about its use. [2009]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on radiotherapy
after breast-conserving surgery.

Full details of the evidence and the committee's discussion are in evidence review H:
breast radiotherapy.

Radiotherapy after mastectomy

1.10.10 Offer adjuvant postmastectomy radiotherapy to people with node-
positive (macrometastases) invasive breast cancer or involved resection
margins. [2018]

1.10.11 Consider adjuvant postmastectomy radiotherapy for people with node-

negative T3 or T4 invasive breast cancer. [2018]

1.10.12 Do not offer radiotherapy following mastectomy to people with invasive

breast cancer who are at low risk of local recurrence (for example, most
people who have lymph node-negative breast cancer). [2018, amended
2023]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on radiotherapy
after mastectomy.

Full details of the evidence and the committee's discussion are in evidence review I:
postmastectomy radiotherapy.

Dose fractionation for external beam radiotherapy

1.10.13 Offer 26 Gy in 5 fractions over 1 week for people with invasive breast
cancer having partial-breast, whole-breast or chest-wall radiotherapy,
without regional lymph node irradiation, after breast-conserving surgery
or mastectomy. [2023]

1.10.14 Consider 40 Gy in 15 fractions over 3 weeks for people with invasive

breast cancer having partial-breast, whole-breast or chest-wall
radiotherapy, without regional lymph node irradiation, after breast-
conserving surgery or mastectomy when they:

• have a diagnosis that increases sensitivity to radiotherapy, or

• have had implant-based reconstruction, or

• have any other factor that could mean having radiotherapy over 3 weeks is
more acceptable (such as high BMI or fibromyalgia). [2023]

1.10.15 When discussing the benefits and risks of the 2 regimens, follow the
recommendations on:

• enabling patients to actively participate in their care in the NICE guideline on

patient experience in adult NHS services, and

• communicating risks, benefits and consequences in the NICE guideline on

shared decision making. [2023]

1.10.16 Offer 40 Gy in 15 fractions over 3 weeks for people with invasive breast
cancer having regional lymph node irradiation, with or without whole-
breast or chest-wall radiotherapy, after breast-conserving treatment or

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Early and locally advanced breast cancer: diagnosis and management (NG101)

mastectomy. [2023]

For a short explanation of why the committee made the 2023 recommendations and
how they might affect practice, see the rationale and impact section on dose
fractionation of external beam radiotherapy.

Full details of the evidence and the committee's discussion are in evidence review M:
effectiveness of different external beam hypofractionation radiotherapy regimens in
people with early-stage or locally advanced invasive breast cancer.

Breast boost following breast-conserving surgery

1.10.17 Offer an external beam boost to the tumour bed for women with invasive
breast cancer and a high risk of local recurrence, following whole-breast
radiotherapy. [2009, amended 2018]

1.10.18 Inform women of the risk of side effects associated with an external
beam boost to the tumour bed following whole-breast radiotherapy.
[2009, amended 2018]

Radiotherapy to nodal areas

1.10.19 Do not offer adjuvant radiotherapy to regional lymph nodes to people
with invasive breast cancer who have histologically lymph node-negative
breast cancer. [2009, amended 2018]

1.10.20 Do not offer people with invasive breast cancer adjuvant radiotherapy to
the axilla after axillary clearance. [2009, amended 2023]

1.10.21 Offer adjuvant radiotherapy to the supraclavicular fossa to people with

invasive breast cancer and 4 or more involved axillary lymph nodes.
[2009]

1.10.22 Offer adjuvant radiotherapy to the supraclavicular fossa to people with

invasive breast cancer and 1 to 3 positive lymph nodes if they have other
poor prognostic factors (for example, T3 and/or histological grade 3

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Early and locally advanced breast cancer: diagnosis and management (NG101)

tumours) and good performance status. [2009]

1.10.23 Consider including the internal mammary chain within the nodal
radiotherapy target for people with node-positive (macrometastases)
invasive breast cancer. [2018]

For a short explanation of why the committee made the 2018 recommendation and
how it might affect practice, see the rationale and impact section on radiotherapy to
nodal areas.

Full details of the evidence and the committee's discussion are in evidence review H:
breast radiotherapy.

Intraoperative radiotherapy
1.10.24 For guidance on intraoperative radiotherapy, see the NICE technology
appraisal guidance on the intrabeam radiotherapy system for adjuvant
treatment of early breast cancer. [2018]

1.11 Primary systemic therapy

Neoadjuvant chemotherapy
1.11.1 Offer neoadjuvant chemotherapy to people with ER-negative invasive
breast cancer as an option to reduce tumour size. [2018]

1.11.2 Offer neoadjuvant chemotherapy to people with HER2-positive invasive

breast cancer in line with the NICE technology appraisal guidance on
pertuzumab for the neoadjuvant treatment of HER2-positive breast
cancer. [2018]

1.11.3 Consider neoadjuvant chemotherapy for people with ER-positive invasive

breast cancer as an option to reduce tumour size if chemotherapy is
indicated. [2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on neoadjuvant
chemotherapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

Neoadjuvant chemotherapy regimens

In June 2023, the use of platinums in recommendations 1.11.4 and 1.11.5 was off-label.
See NICE's information on prescribing medicines.

1.11.4 For people with ER/PR/HER2-negative (triple-negative) invasive breast

cancer, consider a neoadjuvant chemotherapy regimen that contains
both a platinum and an anthracycline. [2018]

1.11.5 Discuss the benefits and risks of adding a platinum to an anthracycline-

containing neoadjuvant chemotherapy regimen (see table 6), and in
particular the risk of increased toxicity. [2018]

Table 6 Benefits and risks of adding a platinum to anthracycline-containing

neoadjuvant chemotherapy for triple-negative invasive breast cancer

Effect of adding a platinum to anthracycline-containing (with or

Category
without taxane) neoadjuvant chemotherapy

Adding a platinum improves response rates compared with

Effect on breast anthracycline-based (with or without taxane) chemotherapy.
conservation rate This may mean that some women who would otherwise need a
mastectomy can be offered breast-conserving surgery

Effect on
pathological Adding a platinum improves the chances of all signs of cancer
complete response disappearing in both the breast and lymph nodes in the axilla,
rate (no residual compared with anthracycline-based (with or without taxane)
cancer found at neoadjuvant chemotherapy
surgery)

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Effect of adding a platinum to anthracycline-containing (with or

Category
without taxane) neoadjuvant chemotherapy

No increase in overall survival with platinum-based

Effect on survival
chemotherapy

Adding a platinum may mean that side effects are more severe.
Anaemia, thrombocytopenia, neutropenia and febrile neutropenia
Side effects:
are seen more frequently with platinum-based chemotherapy
Platinum-based
On average, if 1,000 women with triple-negative breast cancer
therapy is only
receive platinum-containing neoadjuvant chemotherapy, about
suitable for fit
70 additional women would experience severe or life-threatening
patients with no
side effects compared with non-platinum neoadjuvant
significant
chemotherapy
comorbidities
Bone marrow suppression and renal problems are likely in older
people

For a short explanation why the committee made the 2018 recommendations and how
they might affect practice, see the rationale and impact section on neoadjuvant
chemotherapy regimens.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

Neoadjuvant endocrine therapy

1.11.6 Consider neoadjuvant endocrine therapy for postmenopausal women
with ER-positive invasive breast cancer as an option to reduce tumour
size if there is no definite indication for chemotherapy. [2018]

1.11.7 Advise premenopausal women that neoadjuvant chemotherapy may be

more likely to produce a clinical response than neoadjuvant endocrine
therapy, but that some tumours do respond to neoadjuvant endocrine
therapy. [2018]

1.11.8 Discuss with women the benefits and risks of neoadjuvant endocrine
therapy compared with neoadjuvant chemotherapy (see table 7). [2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Table 7 Benefits and risks of neoadjuvant endocrine therapy compared with

neoadjuvant chemotherapy for women with ER-positive/HER2-negative breast cancer

Neoadjuvant endocrine
Category Neoadjuvant chemotherapy
therapy

Tamoxifen or an
aromatase inhibitor Chemotherapy given before surgery
started before surgery Only an option for people who would be
Definition
Only an option for women recommended adjuvant (after surgery)
with ER-positive breast chemotherapy
cancer

Tablet taken once a day Intravenous administration in hospital, as an

Administration
at home outpatient

For postmenopausal
women: may be as
effective as neoadjuvant
chemotherapy in terms of
breast conservation rates For postmenopausal women: effective at
and shrinking the tumour improving breast conservation rates and
For premenopausal shrinking the tumour
Effectiveness
women: less effective For premenopausal women: more effective
than neoadjuvant than endocrine therapy at shrinking the
chemotherapy at tumour
shrinking the tumour (but
some tumours may
respond so may be
effective in some women)

If neoadjuvant endocrine
therapy is not effective,
then women may proceed
Potential
to surgery earlier or may –
disadvantages
still need to have
chemotherapy, either
before or after surgery

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Neoadjuvant endocrine
Category Neoadjuvant chemotherapy
therapy

All endocrine therapies:

menopausal symptoms
such as hot flushes
For tamoxifen: increased
risk of thrombosis and
endometrial cancer
For aromatase inhibitors:
joint and muscle pain, Side effects may include nausea and
urogenital symptoms, vomiting, risk of infections that may be life
bone density loss (may threatening, fatigue, neuropathy, cardiac
also occur with tamoxifen toxicity, diarrhoea, constipation, sore
Side effects
in premenopausal mouth, skin and nail changes, risk of blood
women) clots, risk of second malignancies, fluid
Side effects are usually retention, allergic reactions and hair loss
reversible Side effects may persist long term
May allow women to
avoid the additional side
effects of chemotherapy
(although women may
still need adjuvant
chemotherapy after
surgery)

Women should not

become pregnant while
Fertility and taking tamoxifen, or
Often causes temporary infertility
family within 2 months of
May cause permanent infertility
planning stopping, because it may
have adverse effects on
the baby

May take longer than

chemotherapy to shrink The duration of neoadjuvant chemotherapy
Length of
the tumour enough for is shorter than neoadjuvant endocrine
course
breast-conserving therapy
surgery

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on neoadjuvant
endocrine therapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

Radiotherapy after neoadjuvant chemotherapy

1.11.9 Offer local treatment with mastectomy (or, in exceptional cases, breast-
conserving surgery) followed by radiotherapy to people with locally
advanced or inflammatory breast cancer that has been treated with
neoadjuvant chemotherapy. [2009]

1.11.10 Offer postmastectomy radiotherapy after neoadjuvant chemotherapy if

post-treatment histology shows node-positive (macrometastases) breast
cancer or involved resection margins. [2018]

1.11.11 Offer postmastectomy radiotherapy after neoadjuvant chemotherapy if

pretreatment investigations show node-positive (macrometastases)
breast cancer. [2018]

1.11.12 Consider postmastectomy radiotherapy after neoadjuvant chemotherapy

if post-treatment histology shows node-negative T3 breast cancer.
[2018]

1.11.13 Consider postmastectomy radiotherapy after neoadjuvant chemotherapy

if pretreatment investigations show node-negative T3 breast cancer.
[2018]

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Early and locally advanced breast cancer: diagnosis and management (NG101)

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on radiotherapy
after neoadjuvant chemotherapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

1.12 Complications of local treatment and

menopausal symptoms

Lymphoedema
1.12.1 Inform people with breast cancer about lymphoedema and their risk of
developing it after treatment with surgery and radiotherapy (see
recommendation 1.12.2). Give them relevant written information before
treatment to take away and refer back to. [2009]

1.12.2 When informing people with breast cancer about the risk of developing
lymphoedema, advise them that:

• lymphoedema can occur in the arm, breast or chest wall

• they do not need to restrict their physical activity

• there is no consistent evidence of increased risk of lymphoedema associated

with air travel, travel to hot countries, manicures, hot-tub use or sports injuries

• there is no consistent evidence of increased risk of lymphoedema associated

with medical procedures (for example, blood tests, injections, intravenous
medicines and blood pressure measurement) on the treated side, and the
decision to perform medical procedures using the arm on the treated side
should depend on clinical need and the possibility of alternatives. [2018,
amended 2023]

1.12.3 Give people who have had treatment for breast cancer advice on how to
reduce the risk of infection that may cause or exacerbate lymphoedema.
[2009]

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1.12.4 Ensure that people with breast cancer who develop lymphoedema have
prompt access to a specialist lymphoedema service. [2009]

For a short explanation of why the committee made the 2018 recommendation and
how it might affect practice, see the rationale and impact section on lymphoedema.

Full details of the evidence and the committee's discussion are in evidence review B:
management of the positive axilla.

Arm and shoulder mobility

1.12.5 Ensure breast care units have documented local guidelines in place for
postoperative physiotherapy that have been agreed with the
physiotherapy department. Guidelines should cover:

• details of the upper limb exercises to be carried out after surgical or

radiotherapy interventions

• situations where the exercises should be tailored for individual circumstances

and needs

• who should give information and instructions, and at what points in the
person's care this should happen

• how healthcare staff can best deliver information about the exercises. [2023]

1.12.6 Give people who are going to have surgery or radiotherapy for breast
cancer instructions and information on upper limb exercises before their
treatment begins:

• explain the benefits of doing the exercises

• explain when the exercises should be started

• ensure the information is in a format suitable for the person to take away to
refer to later

• answer any questions the person may have on the exercises, or how to perform
them

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• give details about who to contact if more information is needed.

Also see the section on communication in the NICE guideline on patient

experience in adult NHS services. [2023]

1.12.7 Preoperatively identify people who are having surgery for breast cancer
as being at high risk of developing shoulder problems if they have any of
the following factors:

• any pre-existing shoulder conditions, such as:

－ history of shoulder surgery

－ shoulder trauma injury (fracture or shoulder dislocation)

－ frozen shoulder

－ osteoarthritis or rheumatoid arthritis affecting the shoulder

－ non-specific shoulder pain

－ stiffness

－ decreased function

• their BMI is over 30 kg/m2

• they have axillary node clearance planned

• they have radiotherapy to the axilla or supraclavicular nodes planned. [2023]

1.12.8 After surgery, if a person with breast cancer needs previously unplanned
axillary node clearance or radiotherapy to the axilla or supraclavicular
nodes, identify them as being at high risk. [2023]

1.12.9 Offer supervised support when performing upper limb exercises to

people who have been identified as being at high risk of developing
shoulder problems after surgery for breast cancer (see
recommendation 1.12.7 for assessment). [2023]

1.12.10 Consider supervised support when performing upper limb exercises for
people who:

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• are having surgery and have not been identified as being at high risk of
developing shoulder problems (as defined by the criteria in
recommendation 1.12.7), but who may still benefit from supervised support or

• are having radiotherapy without surgery. [2023]

1.12.11 Ensure supervised support for upper limb exercises:

• is available as either individual, group or virtual support, depending on the

person's circumstances, needs and preferences

• is tailored to the person's needs (for example, modifying exercises for people
with more complex needs)

• includes checking that the person is performing the activity correctly

• is delivered by physiotherapy staff members or other appropriately trained

allied health professionals. [2023]

1.12.12 Refer people to the physiotherapy department for individual assessment

and treatment if they report a persistent reduction in arm and shoulder
mobility after breast cancer surgery or radiotherapy. [2023]

For a short explanation of why the committee made the 2023 recommendations and
how they might affect practice, see the rationale and impact section on arm and
shoulder mobility.

Full details of the evidence and the committee's discussion are in evidence review L:
strategies for reducing arm and shoulder problems after breast cancer surgery or
radiotherapy.

Menopausal symptoms
1.12.13 Offer women information and counselling about the possibility of early
menopause and menopausal symptoms associated with breast cancer
treatment. [2009]

1.12.14 Stop systemic hormone replacement therapy (HRT) in women who are
diagnosed with breast cancer. [2009]

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1.12.15 Do not routinely offer HRT (including oestrogen/progestogen

combination) to women with menopausal symptoms and a history of
breast cancer. [2009, amended 2023]

In June 2023, this was an off-label use of HRT, and HRT is

contraindicated in women with a history of breast cancer. See NICE's
information on prescribing medicines.

1.12.16 In exceptional circumstances, offer HRT to women with severe

menopausal symptoms and a history of breast cancer after a discussion
of the associated risks. [2009, amended 2023]

In June 2023, this was an off-label use of HRT, and HRT is

contraindicated in women with a history of breast cancer. See NICE's
information on prescribing medicines.

1.12.17 Consider selective serotonin reuptake inhibitor (SSRI) antidepressants for

women with breast cancer for relieving menopausal symptoms,
particularly hot flushes, but not for those taking tamoxifen. For guidance
on safe prescribing of antidepressants (such as SSRIs) and managing
withdrawal, see NICE's guideline on medicines associated with
dependence or withdrawal symptoms. [2009, amended 2018]

In June 2023, this was an off-label use of SSRIs. See NICE's information
on prescribing medicines.

1.12.18 Do not offer soy (isoflavone), red clover, black cohosh, vitamin E or
magnetic devices to treat vasomotor symptoms in women with breast
cancer. [2009, amended 2023]

1.13 Follow-up

Follow-up imaging
1.13.1 Offer annual mammography for 5 years to all people who have had or are
being treated for breast cancer, including DCIS. For women, continue
annual mammography past 5 years until they enter the NHS Breast

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Screening Programme (NHSBSP) in England or the Breast Test Wales

Screening Programme (BTWSP) in Wales. [2009, amended 2023]

1.13.2 Do not perform mammography of the ipsilateral soft tissues after

mastectomy. [2009]

1.13.3 Do not routinely use ultrasound or MRI for post-treatment surveillance in

people who have had treatment for invasive breast cancer or DCIS.
[2009, amended 2023]

Clinical follow-up
1.13.4 Ensure all people who have had treatment for breast cancer have an
agreed, written care plan, recorded in their notes by a named healthcare
professional (or professionals) from the multidisciplinary team. Give a
copy to the person and to their GP. The plan should include:

• designated named healthcare professionals

• dates for review of any adjuvant therapy

• details of surveillance mammography

• signs and symptoms to look out for and seek advice on

• contact details for immediate referral to specialist care

• contact details for support services, for example, support for people with
lymphoedema. [2009, amended 2023]

1.14 Lifestyle
1.14.1 Advise people who have had or are being treated for breast cancer that a
healthy lifestyle is associated with a lower risk of recurrence, and that
this should include:

• achieving and maintaining a healthy weight (see the NICE guidelines on

preventing excess weight gain and obesity)

• limiting alcohol intake to below 5 units per week

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• regular physical activity (see the NICE guideline on physical activity for adults).
[2018]

1.14.2 For guidance on smoking cessation, see the NICE guideline on tobacco:
preventing uptake, promoting quitting and treating dependence. [2018]

For a short explanation of why the committee made the 2018 recommendations and
how they might affect practice, see the rationale and impact section on lifestyle.

Full details of the evidence and the committee's discussion are in evidence review K:
lifestyle.

Terms used in this guideline

Upper limb exercises

Upper limb exercises predominantly focus on gentle shoulder range-of-movement
exercises and stretches aimed at regaining full and pain-free range of movement of the
shoulder following breast cancer surgery and/or radiotherapy. The term can also refer to
exercises that progress onto strengthening the shoulder and arm.

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Recommendations for research

The guideline committee has made the following key recommendations for research.

1 Surgery to the breast

What is the optimum tumour-free margin width after breast-conserving surgery for women
with ductal carcinoma in situ (DCIS) and invasive breast cancer? [2018]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on surgery to the breast.

Full details of the evidence and the committee's discussion are in evidence review A:
surgery to the breast.

2 Adjuvant bisphosphonate therapy

Which groups of people with early and locally advanced breast cancer would benefit from
the use of adjuvant bisphosphonates? [2018]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on adjuvant bisphosphonate therapy.

Full details of the evidence and the committee's discussion are in evidence review G:
adjuvant bisphosphonates.

3 Breast reconstruction
What are the long-term outcomes for breast reconstruction in women having radiotherapy
to the chest wall? [2018]

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For a short explanation of why the committee made the recommendation for research,
see the rationale section on breast reconstruction.

Full details of the evidence and the committee's discussion are in evidence review I:
postmastectomy radiotherapy.

4 Neoadjuvant endocrine therapy in premenopausal

women
Is neoadjuvant endocrine therapy safe in premenopausal women with early breast cancer?
[2018]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on neoadjuvant endocrine therapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

5 Neoadjuvant endocrine therapy in

postmenopausal women
Is there a benefit for neoadjuvant endocrine therapy in postmenopausal women with early
breast cancer? [2018]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on neoadjuvant endocrine therapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

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6 Neoadjuvant treatment
What are the indications for postmastectomy radiotherapy after neoadjuvant
chemotherapy? [2018]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on radiotherapy after neoadjuvant chemotherapy.

Full details of the evidence and the committee's discussion are in evidence review J:
neoadjuvant treatment of early and locally advanced breast cancer.

7 Strategies to reduce arm and shoulder problems

What is the most effective and cost-effective way of delivering the intervention (for
example, type of physiotherapy or exercise, mode of delivery, number of sessions) to
reduce arm and shoulder problems after breast cancer surgery or radiotherapy, and what
is the acceptability of the intervention for different groups, such as:

• women, men, trans people and non-binary people

• people from minority ethnic family backgrounds

• people with learning disabilities or cognitive impairment, or physical disabilities, or

both

• neurodiverse people? [2023]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on arm and shoulder mobility.

Full details of the evidence and the committee's discussion are in evidence review L:
strategies for reducing arm and shoulder problems after breast cancer surgery or
radiotherapy.

8 Adherence and satisfaction for interventions to

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reduce arm and shoulder problems

What is the adherence to, and satisfaction with, different intervention formats (for
example, individual, group, virtual, and face to face) to reduce arm and shoulder problems
after breast cancer surgery or radiotherapy, and what is the impact of greater adherence
on effectiveness for different groups, such as:

• women, men, trans people and non-binary people

• people from minority ethnic family backgrounds

• people with learning disabilities or cognitive impairment, or physical disabilities, or

both

• neurodiverse people? [2023]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on arm and shoulder mobility.

Full details of the evidence and the committee's discussion are in evidence review L:
strategies for reducing arm and shoulder problems after breast cancer surgery or
radiotherapy.

9 Effectiveness of 26 Gy in 5 fractions over 1 week

regimen in people receiving breast reconstruction
What is the effectiveness of radiotherapy given in 26 Gy in 5 fractions over 1 week
compared with 40 Gy in 15 fractions over 3 weeks in people with early or locally advanced
invasive breast cancer who are offered breast reconstruction? [2023]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on dose fractionation of external beam radiotherapy.

Full details of the evidence and the committee's discussion are in evidence review M:
effectiveness of different external beam hypofractionation radiotherapy regimens in
people with early-stage or locally advanced invasive breast cancer.

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10 Effectiveness of 26 Gy in 5 fractions over 1 week

regimen in people receiving nodal irradiation
What is the effectiveness of radiotherapy given in 26 Gy in 5 fractions over 1 week
compared with 40 Gy in 15 fractions over 3 weeks in people with early or locally advanced
invasive breast cancer who are also offered nodal irradiation? [2023]

For a short explanation of why the committee made the recommendation for research,
see the rationale section on dose fractionation of external beam radiotherapy.

Full details of the evidence and the committee's discussion are in evidence review M:
effectiveness of different external beam hypofractionation radiotherapy regimens in
people with early-stage or locally advanced invasive breast cancer.

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Rationale and impact

These sections briefly explain why the committee made the recommendations and how
they might affect practice. They link to details of the evidence and a full description of the
committee's discussion.

Providing information and psychological support

Recommendations 1.2.3 and 1.2.4

Why the committee made the recommendations

The committee agreed, based on their clinical expertise, that continued improvement in
breast cancer survival as well as post-diagnosis quality of life needs ongoing research into
new or refined treatment options to allow further optimisation of care.

People having treatment for breast cancer should be advised about options for preserving
their fertility, so the existing NICE guideline on this topic was cross-referred to.

How the recommendations might affect practice

Recruitment into clinical trials wherever possible is already standard practice, so the
recommendation is unlikely to result in a change in practice.

Discussion of fertility options is already standard practice, so the recommendation is

unlikely to result in a change in practice.

Return to recommendations

Surgery to the breast

Recommendations 1.3.1 and 1.3.2

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Why the committee made the recommendations

There was some evidence that there was a reduced risk of ductal carcinoma in situ (DCIS)
local recurrence if tissue margins were greater than 0 mm, so the committee
recommended further surgery (re-excision or mastectomy) to extend the margins if
needed. Although there was no consistent evidence about tissue margins for invasive
breast cancer, the committee agreed that further surgery should be offered.

The committee agreed that complete excision of the tumour with clear margins was
essential for the high-quality care of people with DCIS or invasive breast cancer.

Although there was evidence that aiming for wider margins reduced local recurrence, this
did not improve overall survival. In addition, aiming for wider margins could lead to some
people having unnecessary extra surgery. Given this uncertainty, the committee agreed
the importance of personalised care and discussion to decide whether further surgery is
needed.

There was not enough evidence to clearly define an optimum margin width between 0 mm
and 2 mm to minimise local recurrence rates and minimise further surgery. So, the
committee agreed that this was an important topic for further research and made a
recommendation for research on the optimum tumour-free margin width after surgery to
the breast.

How the recommendations might affect practice

The rates of further surgery currently vary across the country. Although the committee
noted that the recommendations will reinforce current best practice, there may be some
centres that will need to amend their practice in order to follow these recommendations.

Return to recommendations

Evaluation and management of a positive axillary

lymph node
Recommendations 1.4.7 to 1.4.10

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Why the committee made the recommendations

There was no new evidence that led the committee to change from the existing
recommended practice (as recommended in the previous NICE guideline CG80) of:

• offering axillary clearance to people with preoperatively pathologically proven

involvement of the axillary lymph nodes

• not offering axillary treatment after primary surgery to people with isolated tumour
cells in their sentinel lymph nodes.

The committee agreed that current evidence shows that further axillary treatment after
primary surgery does not improve survival for people with micrometastases and there are
risks such as lymphoedema, so further treatment should not be offered to this population.
There were unclear benefits and risks of further axillary treatment after primary surgery in
people with only 1 or 2 sentinel lymph node macrometastases who have had breast-
conserving surgery and have been advised to have whole-breast radiotherapy and
systemic therapy, so the committee agreed that the risks and benefits of further treatment
should be discussed with this group.

Studies of neoadjuvant therapy were excluded from the evidence review.

How the recommendations might affect practice

The committee agreed that the recommendations will result in a minor change in practice
because some centres currently use mainly surgery and may not use radiotherapy. In
addition, more time may need to be factored in to plan and deliver radiotherapy treatment.

Return to recommendations

Breast reconstruction
Recommendations 1.5.2 to 1.5.5

Why the committee made the recommendations

There was not much good evidence, but the committee agreed that the main benefits of
immediate breast reconstruction compared with delayed reconstruction are improved

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aesthetic satisfaction, improved symmetry, improved health-related quality of life, lower

overall rates of complications and a reduced need for further surgery. The committee
agreed that in some circumstances, there are advantages to delayed reconstruction
compared with immediate reconstruction (for example, reduced mastectomy flap loss and
capsular contracture). Therefore, delayed reconstruction should also be an option for
women who wish to have a reconstruction after mastectomy. The committee also agreed
that the option of no reconstruction should also be discussed, because this may be the
preferred option for some women.

In addition, although radiotherapy can impact on outcomes after breast reconstruction,

there was no consistent evidence for worse outcomes between radiotherapy delivered
after immediate reconstructions compared with radiotherapy before delayed
reconstructions. Therefore, the committee agreed that immediate reconstruction should
be offered regardless of plans for chest-wall radiotherapy.

There is little evidence regarding longer-term outcomes and different types of

reconstruction. Because of this, the committee agreed that more research is needed to
understand whether immediate breast reconstruction or delayed breast reconstruction is
better in women who may need postmastectomy radiotherapy. So, they made a
recommendation for research on long-term outcomes for breast reconstruction in women
having radiotherapy to the chest wall.

How the recommendations might affect practice

The recommendations may result in a substantial change in practice because many
centres do not routinely offer immediate breast reconstruction to all women (especially
those who have been advised to have radiotherapy). The impact will depend on how many
immediate reconstructions are already carried out. In addition, the uptake of immediate
breast reconstruction will also depend on women's preferences. There may be cost
savings associated with immediate reconstructions because fewer surgical procedures are
needed (reconstruction is done at the same time as mastectomy and there are lower rates
of additional symmetrisation surgery).

Return to recommendations

Predictive factors
Recommendations 1.6.1, 1.6.3 and 1.6.5

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Why the committee made the recommendations

There was not enough good evidence, so the committee agreed, using a formal consensus
scoring system and their knowledge and experience, that progesterone receptor (PR)
status should be assessed for all invasive breast cancers because:

• it will help when tailoring adjuvant therapy

• it will reduce delays in starting treatment

• if people are already having testing at this stage, their PR status can be assessed
without them having to wait for additional test results.

The committee also agreed that oestrogen receptor (ER), PR and human epidermal growth
factor receptor 2 (HER2) status assessments should be requested simultaneously at the
time of initial diagnosis to ensure that results are available at the initial preoperative
multidisciplinary team meeting (as well as the postoperative meeting). This will avoid
delays and the need for additional discussions.

How the recommendations might affect practice

Most people with invasive breast cancer have PR testing in current practice, although it is
not always performed at diagnosis. The recommendations should reduce variation in
practice and delays in starting treatment, and the need for pathology results to be
discussed at more than 1 multidisciplinary meeting, so may lead to a small cost saving.

Return to recommendations

Adjuvant therapy planning

Recommendations 1.6.8 and 1.6.9

Why the committee made the recommendations

Good evidence showed that the prognostic tool PREDICT is an accurate tool to estimate
prognosis and the benefits of treatment in most people.

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How the recommendations might affect practice

The committee agreed that most healthcare professionals already use the PREDICT tool,
so this recommendation will not mean a big change in practice.

Return to recommendations

Ovarian function suppression

Recommendations 1.7.4 and 1.7.5

Why the committee made the recommendations

There was evidence that ovarian function suppression increased overall survival when
combined with tamoxifen, and that women who have had chemotherapy benefited more.
However, ovarian function suppression did not improve disease-free survival. In addition, it
induces a temporary menopause and can worsen the menopausal symptoms seen with
tamoxifen.

Given the limited evidence of benefits and the side effects of the treatment, the
committee agreed that healthcare professionals should discuss the potential benefits and
risks with women. This will help women decide which treatment is right for them.

How the recommendations might affect practice

There is variation among centres in the use of ovarian function suppression, so the
recommendations should lead to greater consistency and improve access to the
treatment, even though not all women will wish to have it. There will be an increase in
required resources for centres that do not currently provide ovarian function suppression
because additional appointments will be needed to administer the medication and monitor
side effects. However, this was not anticipated to be a substantial cost increase because
of the number of centres already offering ovarian function suppression. Further, increased
costs will be at least partially offset by improvements in survival outcomes.

Return to recommendations

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Extended endocrine therapy

Recommendations 1.7.6 to 1.7.9

Why the committee made the recommendations

Good evidence showed that switching to an aromatase inhibitor after 5 years of tamoxifen
improved disease-free survival compared with postmenopausal women who had only
received tamoxifen for 5 years, with the benefits being greater in those women who had a
greater risk of disease recurrence.

The evidence showed no benefit in terms of disease-free survival or overall survival from
continuing tamoxifen beyond 5 years. However, some of the studies on tamoxifen were
conducted in the 1980s and may not be relevant to current practice. In the committee's
experience, continuing tamoxifen can be beneficial for some women.

However, evidence showed that being on endocrine therapy for more than 5 years can
increase the risk of problems such as endometrial cancer, osteoporosis, toxicity and
phlebitis. The committee agreed that people will often prioritise survival even if this means
they will have a reduced quality of life, but that people need to be informed about the
possible benefits and risks so they can make a choice.

Because of the risk of problems with taking endocrine therapy for more than 5 years, the
committee agreed that healthcare professionals should discuss the potential benefits and
risks with women to help them make an informed choice about treatment, based on their
own risk factors.

How the recommendations might affect practice

Some centres already review treatment at 5 years and continue endocrine therapy with
tamoxifen or an aromatase inhibitor when it could benefit women. Because a large number
of women will be affected by these recommendations, the resource impact will be large for
centres that are not currently providing treatment after 5 years.

Return to recommendations

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Endocrine therapy for ductal carcinoma in situ

Recommendations 1.7.10 to 1.7.12

Why the committee made the recommendations

There was good evidence that tamoxifen after breast-conserving surgery for ER-positive
DCIS improved disease-free survival and reduced rates of local recurrence in women who
did not have radiotherapy. Because of their concerns about over-treatment, the committee
agreed that women who were at higher risk (those who should have had radiotherapy, but
who did not receive it) would benefit more. There was no evidence available for aromatase
inhibitors; however, the committee agreed they would likely produce similar improvements
in disease-free survival and reductions in local recurrence as tamoxifen. Therefore, the
committee recommended endocrine therapy, rather than specifically tamoxifen.

The committee agreed that the benefits and risks of endocrine therapy should be
discussed with the woman because of the potential treatment-related complications, such
as menopausal symptoms, and the impact on family planning.

How the recommendations might affect practice

Offering endocrine therapy after initial treatment of DCIS will be a change of practice
because it is not currently routinely offered to these women. However, because of the
small number of people with DCIS who will not receive radiotherapy, and the low cost of
the medicines, the committee agreed that the impact will not be significant.

Return to recommendations

Adjuvant chemotherapy for invasive breast cancer

Recommendations 1.8.1 to 1.8.3

Why the committee made the recommendations

There was good evidence of improved survival when taxanes are added to anthracycline-
based chemotherapy in people with node-positive and node-negative breast cancer. In
both groups, the benefits and risks of treatment should be discussed because of the

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potential side effects associated with taxanes. Three-weekly docetaxel was identified as a
regimen with potentially more toxicity than weekly or fortnightly paclitaxel.

How the recommendations might affect practice

These recommendations may result in a substantial change in practice because of
increased taxane use, particularly for people with node-negative breast cancer and
comorbidities.

In addition, there will be an increase in weekly and fortnightly chemotherapy regimens

being offered (for people who cannot tolerate 3-weekly regimens). These regimens have a
higher cost because they are more resource intensive, and may affect capacity in
chemotherapy services.

Return to recommendations

Biological therapy
Recommendation 1.8.5

Why the committee made the recommendation

There was evidence that adjuvant trastuzumab can improve disease-free survival and
overall survival in some people with T1a and T1b HER2-positive invasive breast cancer who
were treated with adjuvant trastuzumab and chemotherapy. However, only a small number
of people will benefit from this treatment and, because trastuzumab can cause heart
problems, it is important to avoid offering it to people who do not need it. Because of this,
the committee agreed that adjuvant trastuzumab should be an option for women with T1a
and T1b tumours rather than a standard treatment.

Combined chemotherapy and trastuzumab was not found to be cost effective when
compared with chemotherapy alone. However, the committee agreed that it was more
appropriate to compare combined chemotherapy and trastuzumab with no treatment
because these are the strategies that are likely to be used in clinical practice. Because it is
the HER2 positivity that increases risk of recurrence for people with small (T1a and T1b)
tumours, it does not make sense from a clinical perspective to not treat the component
that is increasing risk (that is, trastuzumab treatment for HER2 positivity). Further, the

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effect of chemotherapy alone in the economic model may be overestimated because the
data may not fully reflect the population under consideration.

How the recommendation might affect practice

Currently, T1 tumours are not routinely treated with adjuvant trastuzumab, so this
recommendation will lead to a change in practice. However, the committee agreed that the
number of additional people having treatment would be small, so the impact on current
practice would be minor and unlikely to require a substantial increase in resources.

Return to recommendation

Adjuvant bisphosphonate therapy

Recommendations 1.9.1 to 1.9.3

Why the committee made the recommendations

There was good evidence that treatment with sodium clodronate and zoledronic acid
improved disease-free and overall survival in postmenopausal women with node-positive
invasive breast cancer.

There was little evidence of benefit for other bisphosphonates. The committee
recommended considering zoledronic acid or sodium clodronate treatment for other high-
risk populations (such as postmenopausal women with node-negative invasive breast
cancer and a high risk of recurrence), based on the evidence that sodium clodronate has
overall survival benefits in mixed populations.

Although there is evidence that intravenous (IV) bisphosphonates have a higher risk of
osteonecrosis of the jaw, oral bisphosphonates have a higher risk of gastrointestinal
problems. There is also a risk of atypical femoral fractures and osteonecrosis of the
external auditory canal with bisphosphonates. Because each drug and regimen has
different risks, the potential benefits and risks should be discussed with women to help
them make an informed choice.

There was little evidence on survival, particularly for premenopausal women on ovarian
suppression, those with node-positive or node-negative disease, and those with positive

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or negative oestrogen or progestogen statuses. There was not enough evidence to make a
recommendation relating to the use of adjuvant bisphosphonates in premenopausal
women. The committee agreed that further research is needed to determine the long-term
survival benefits and the groups of people most likely to benefit from adjuvant
bisphosphonates. So, they made a recommendation for research on groups of people who
would benefit from the use of adjuvant bisphosphonates.

The committee did not look at the evidence relating to the use of bisphosphonates for
bone health or for the use of baseline dual-energy X-ray absorptiometry (DEXA) scanning,
so did not make any new recommendations.

How the recommendations might affect practice

Bisphosphonates are not consistently offered as adjuvant treatment, so this
recommendation may lead to an increase in prescribing.

GPs may need to monitor people taking oral bisphosphonates, but this is likely to be an
annual review so would not have a large workload impact. However, people may make
more GP visits if they have side effects from bisphosphonate treatment.

The committee agreed that IV bisphosphonates would usually be administered at the same
time as chemotherapy drugs for the first 6 months of treatment, so this would not result in
extra hospital visits for this period. After that, extra visits for administration and monitoring
may be needed.

Return to recommendations

Radiotherapy techniques
Recommendations 1.10.1 and 1.10.2

Why the committee made the recommendations

There was good evidence that radiotherapy to the internal mammary nodes reduced
locoregional recurrence and improved survival. However, the committee took into account
the potential for lung and heart toxicity, so recommended using a radiotherapy technique
that minimises this risk.

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There was evidence that deep inspiratory breath-hold radiotherapy techniques reduce the
mean radiotherapy heart dose for adults with left-sided invasive breast cancer receiving
whole-breast radiotherapy. The committee did not identify any harms. There was also
evidence that deep inspiration breath-hold radiotherapy techniques did not reduce the
target coverage of whole-breast radiotherapy.

There was no evidence about the use of deep inspiration breath-hold radiotherapy
techniques for people with right-sided breast cancer, so the committee did not make
separate recommendations for this subgroup.

How the recommendations might affect practice

Using a radiotherapy technique that minimises the dose to the lung and heart is likely to
need a change in practice for many centres. There will be some impact on resources in
order to implement this recommendation because additional training will be needed, and
local protocols will need developing. However, the long-term impact on resources will be
minimal: some additional planning time will be needed but there is no impact on the length
or number of radiotherapy sessions.

Currently, deep inspiratory breath-hold radiotherapy techniques are not routinely offered
to people with invasive breast cancer having whole-breast radiotherapy. However, the
committee noted that the Royal College of Radiologists has produced consensus
statements that advise using this technique, and that many centres already offer it. The
recommendation will ensure consistent practice and ensure that people can access the
best care.

Return to recommendations

Radiotherapy after breast-conserving surgery

Recommendations 1.10.3 to 1.10.8

Why the committee made the recommendations

There is evidence that whole-breast radiotherapy after breast-conserving surgery reduces
the risk of recurrence and increases overall survival. It also decreases rates of depression
and anxiety.

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However, because the risk of breast cancer recurring at 5 years is very low and there are
harms associated with radiotherapy, the benefits of radiotherapy for women with a very
low risk of recurrence are less certain. For these women, the committee agreed that
healthcare professionals should fully discuss the benefits and risks with women before a
decision is made.

Good evidence showed that partial-breast radiotherapy led to similar results to whole-
breast radiotherapy after breast-conserving surgery in women with a low risk of local
recurrence. In addition, it may have fewer treatment-related adverse effects. There was
evidence for multicatheter interstitial brachytherapy, but this was not recommended
because it is not currently available in England.

How the recommendations might affect practice

Most women are already offered radiotherapy after breast-conserving surgery so this
reflects current practice, but more time may be needed to discuss the balance of benefits
and risks with women.

The committee was aware that current practice for external beam partial-breast
radiotherapy after breast-conserving surgery is based on the Royal College of
Radiologists' 2016 consensus statement, so there would be no change to recommended
practice.

Return to recommendations

Radiotherapy after mastectomy

Recommendations 1.10.10 to 1.10.12

Why the committee made the recommendations

The committee agreed that adjuvant postmastectomy radiotherapy should be offered to
people who have macroscopically node-positive invasive breast cancer or have involved
resection margins. This is because the evidence showed a beneficial effect on survival and
local recurrence. Although the evidence was limited and the committee acknowledged that
radiotherapy is associated with lung and cardiac morbidity, they concluded that for this
group of women, the benefits of radiotherapy outweigh the harms.

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There was evidence of a beneficial effect of postmastectomy radiotherapy on local

recurrence and overall survival for people with node-negative invasive breast cancer.
However, the committee agreed that there was a risk of over-treatment if all people with
node-negative invasive breast cancer received postmastectomy radiotherapy. Therefore,
the committee recommended that adjuvant postmastectomy radiotherapy should be
considered for people with node-negative T3 or T4 invasive breast cancer. There was no
evidence for this specific subgroup, but they would be considered at increased risk of
recurrence and mortality relative to smaller, node-negative invasive breast cancers
because of the size of the tumour.

The committee agreed that radiotherapy after mastectomy should not be offered to
women with early invasive breast cancer who are at low risk of local recurrence (for
example, most women who are lymph node-negative) because the evidence showed
limited benefit in survival and local recurrence.

How the recommendations might affect practice

The committee agreed that the recommendations will reinforce current practice, so there
would be little change in practice.

Return to recommendations

Dose fractionation of external beam radiotherapy

Recommendations 1.10.13 to 1.10.16

Why the committee made the recommendations

The committee noted that most centres use regimens of either 40 Gy in 15 fractions or
26 Gy in 5 fractions. However, there was variation between centres in which external beam
hypofractionation regimen they used.

The evidence compared a number of different external beam hypofractionation regimens,

but the committee focused on the evidence from 2 randomised controlled trials (RCTs)
that compared clinical effectiveness and safety, and a cost-effectiveness analysis, of the 2
hypofractionation regimens that are established in current practice (40 Gy in 15 fractions
over 3 weeks and 26 Gy in 5 fractions over 1 week). High-quality to very low-quality

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evidence showed that the effects of both external beam hypofractionation regimens were
comparable, with no clinically important differences between treatment arms for all-cause
mortality, breast cancer-related mortality or disease recurrence. Economic evidence
showed the 26 Gy in 5 fractions as an effective use of NHS resources compared with
40 Gy in 15 fractions and supported its use in current practice. In addition, the committee
noted that in their experience, most people preferred to attend radiotherapy appointments
over the course of 1 week rather than over 3 weeks for practical reasons related to fewer
trips to the hospital (for example, reduced travelling time and costs, less time off work or
from caring responsibilities). The committee recognised how the COVID-19 pandemic had
also impacted current practice and had accelerated the change to implement the shorter
26 Gy in 5 fractions regimen.

The evidence showed that there was a higher incidence of outcomes related to clinician-
assessed adverse events at 5 years and quality-of-life measurements (related to harder or
firmer breasts) for people who were given 26 Gy in 5 fractions compared with 40 Gy in 15
fractions. However, with the exception of a quality-of-life outcome related to swollen
breasts, the differences in effect between the 2 regimens were not clinically significant.
The committee agreed that in their experience, 26 Gy in 5 fractions is widely accepted by
people, despite the small risk of increased adverse events. After taking into account the
benefits of a shorter regimen and the impact of the adverse events, the committee
recommended the use of 26 Gy in 5 fractions for people having partial-breast, whole-
breast or chest-wall radiotherapy, without nodal irradiation, after breast-conserving
surgery or mastectomy.

The committee noted that the evidence presented was from populations who were
receiving whole-breast radiotherapy. There was no evidence for people who are at lower
risk of disease recurrence than those included in the evidence base and who are offered
partial-breast radiotherapy because of their reduced risk. However, the committee agreed
that, considering the already lower risk for this population, the findings of 26 Gy in 5
fractions in the higher-risk population could be extrapolated to also cover the lower-risk
population. The committee also noted that the decision over whether someone has partial-
breast or whole-breast radiotherapy can change based on clinical judgement and
assessment of the treatment area. As such, the committee agreed that if partial-breast
radiotherapy were excluded, the recommendations would not be in line with current
practice and may disadvantage a large group of people.

The committee recognised that there may be circumstances when 40 Gy in 15 fractions

would be more suitable than 26 Gy in 5 fractions. For example, the committee noted that,

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in their clinical experience, some groups of people, such as those with a high BMI or
fibromyalgia, may experience a greater number of acute adverse events from the
5-fraction regimen (for example, skin reactions, breast oedema or pain). Therefore, some
people may prefer the 15-fraction regimen. The committee also noted that the number of
people in the studies who had undergone breast reconstruction surgery was small, and it
was difficult to determine the most effective hypofractionation regimen for this group. The
15-fraction regimen may also be used for those whose dosimetry is outside that used in
the FAST-Forward trial. The committee highlighted the importance of shared decision
making for these groups and ensuring that people are aware of the benefits and risks of
each treatment option. As such, the committee made a recommendation that 40 Gy in 15
fractions over 3 weeks should be considered for some groups of people, and that its use
should be agreed between the person and their care team.

The committee discussed the eligibility criteria for some of the trials in the evidence and
noted that people who received nodal radiotherapy were excluded from the main study
populations. They highlighted that there are particular concerns around adverse effects
such as lymphoedema for people who received regional lymph node irradiation. The
committee acknowledged that future trials and the FAST-Forward nodal sub-study results
may address some of these concerns, but until further evidence is available the 40 Gy in
15 fractions regimen should continue to be used for this group.

There was limited evidence comparing the 2 hypofractionation regimens in people having
breast reconstruction or having regional lymph node irradiation. As such, the committee
developed recommendations for research on people having breast reconstruction
(including autologous breast reconstruction, but particularly implant-based reconstruction)
and people having regional lymph node irradiation. These should provide clinicians with an
increased understanding of how effective the 26 Gy in 5 fractions regimen is for these
groups in future.

How the recommendations might affect practice

The recommendations may reduce variation in practice, with most people being offered
26 Gy in 5 fractions rather than 40 Gy in 15 fractions. This is already current practice in
many centres and will not have a major impact for those centres. In those centres where
26 Gy in 5 fractions is not yet current practice, there will be significant cost savings and
capacity will be released for more appointments. For places where 40 Gy in 15 fractions is
used more routinely, these recommendations may increase the number of people who are
offered 26 Gy over 5 fractions. This will reduce the treatment duration and the costs

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associated with treatment.

Return to recommendations

Radiotherapy to nodal areas

Recommendation 1.10.23

Why the committee made the recommendation

There was good evidence that radiotherapy to the internal mammary nodes reduced
locoregional recurrence and improved survival. However, the committee took into account
the potential for lung and heart toxicity, and agreed the importance of using a
radiotherapy technique that minimises this risk.

How the recommendation might affect practice

This recommendation is likely to need a change in practice for many centres. There will be
some impact on resources in order to implement this recommendation because additional
training will be needed, and local protocols will need developing. However, the long-term
impact on resources will be minimal: some additional planning time will be needed but
there is no impact on the length or number of radiotherapy sessions.

Return to recommendation

Neoadjuvant chemotherapy
Recommendations 1.11.1 to 1.11.3

Why the committee made the recommendations

There was good evidence to say that having chemotherapy before surgery (neoadjuvant
chemotherapy) enables some women to have breast-conserving surgery who would
otherwise have had total removal of their breast. The committee agreed that the response
to neoadjuvant therapy could help guide the choice of subsequent adjuvant therapy.

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How the recommendations might affect practice

The committee agreed that the recommendations would not result in a major change in
practice because neoadjuvant chemotherapy is already offered in many centres. These
recommendations will help improve consistency in practice.

Return to recommendations

Neoadjuvant chemotherapy regimens

Recommendations 1.11.4 and 1.11.5

Why the committee made the recommendations

There was evidence that platinum-containing neoadjuvant chemotherapy regimens can
improve pathological complete response rate and breast conservation rate in people with
triple-negative invasive breast cancer. However, the committee took into account that
platinum-containing regimens can cause anaemia, thrombocytopenia, neutropenia and
febrile neutropenia, as well as bone marrow problems and renal problems in older people.
The committee agreed that healthcare professionals should have a full discussion with
people about the benefits and risks of these regimens.

There was no evidence on people with the BRCA germline mutation, so the committee did
not make separate recommendations for this subgroup.

How the recommendations might affect practice

Currently, platinum-containing neoadjuvant chemotherapy is not routinely offered to
people with triple-negative early and locally advanced breast cancer, although the
committee was aware that some centres may offer it. The recommendations will therefore
bring a change in practice and will make practice more consistent across the NHS. The
committee estimated that approximately 30% to 40% of people receiving neoadjuvant
chemotherapy may be affected by the recommendations.

Return to recommendations

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Neoadjuvant endocrine therapy

Recommendations 1.11.6 to 1.11.8

Why the committee made the recommendations

For postmenopausal women, there was some evidence that breast conservation rates,
changes in tumour size and overall survival are the same with neoadjuvant endocrine
therapy and neoadjuvant chemotherapy. Endocrine therapy is safer and has fewer side
effects than chemotherapy, but there was not enough evidence to recommend endocrine
therapy over chemotherapy for every woman. The committee agreed that healthcare
professionals should discuss the potential benefits and risks with women to help them
decide which treatment is right for them and that more research is needed to say whether
neoadjuvant endocrine therapy is as effective as neoadjuvant chemotherapy.

The evidence for premenopausal women showed that neoadjuvant chemotherapy was
more effective than endocrine therapy, but that endocrine therapy may be effective in
some women. However, some women may prefer endocrine therapy because it is safer
and has fewer side effects. Because of this, the committee agreed that healthcare
professionals should discuss the potential benefits and risks with women to help them
decide which treatment is right for them. The committee agreed that more research is
needed on the long-term safety of neoadjuvant endocrine therapy, and to identify which
premenopausal women will benefit from it. So, they made recommendations for research
on the safety of neoadjuvant endocrine therapy in premenopausal women and
postmenopausal women with early breast cancer.

How the recommendations might affect practice

Neoadjuvant endocrine therapy is already being used, although there may be an increase
in the number of people being offered it.

Return to recommendations

Radiotherapy after neoadjuvant chemotherapy

Recommendations 1.11.10 to 1.11.13

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Why the committee made the recommendations

There was not enough evidence to recommend subgroups of women in whom
postmastectomy radiotherapy could be safely omitted after neoadjuvant chemotherapy.
Therefore, the committee agreed that the recommendations for postmastectomy
radiotherapy among people who have not received neoadjuvant chemotherapy applied to
this population.

People with node-negative T4 cancer were not included in this review because they are
covered by the recommendation from the previous guideline which has been retained.

Women who respond well to neoadjuvant chemotherapy may derive less benefit from
radiotherapy, but the committee agreed that further research was required to determine if
the risks of radiotherapy outweighed the benefits in some women. So, they made a
recommendation for research on the indications for postmastectomy radiotherapy after
neoadjuvant chemotherapy.

How the recommendations might affect practice

The committee noted that decisions about postmastectomy radiotherapy after
neoadjuvant chemotherapy are currently based on pretreatment investigations, so there
will be no change to practice.

Return to recommendations

Lymphoedema
Recommendation 1.12.2

Why the committee made the recommendation

Good evidence showed that there is no increased risk of lymphoedema associated with
maintaining exercise levels after axillary intervention, so the committee agreed that people
should not restrict or avoid physical activity.

Although the evidence was limited and mixed, the committee concluded that there is no
consistent evidence of increased risk of lymphoedema associated with air travel, travel to
hot countries, manicures, hot-tub use, sports injuries, or medical procedures on the

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treated side.

How the recommendation might affect practice

Advice about preventing lymphoedema is already being provided as part of routine care,
so there is unlikely to be much change in practice. However, the recommendation will lead
to greater consistency in the advice offered. It should also reduce inequality and improve
the quality of standard care if people who have had axillary treatment need immunisations
or elective procedures.

Return to recommendation

Arm and shoulder mobility

Recommendations 1.12.5 to 1.12.12

Why the committee made the recommendations

The committee noted there was very little high-quality evidence for any of the outcomes,
and most of the evidence was low to very low quality. The committee agreed that they did
not feel confident in making recommendations based on low-quality evidence from mainly
single studies. Therefore, they used their clinical knowledge and experience alongside
high-quality evidence from 1 UK-based RCT to support their decision making. This
evidence showed improved outcomes with a physiotherapy-led structured supervised
exercise programme in addition to usual care for reduction of pain, quality-of-life
improvement and adherence to arm and shoulder exercises in people with a higher risk of
developing shoulder problems. The trial provided all participants with information leaflets
about exercises to help with arm and shoulder mobility after breast cancer surgery. This
reflects standard practice in the UK, and the committee agreed it was important to reflect
this advice in the recommendations. The recommendations also highlight that instructions
on upper limb exercises and information should be discussed, explained and clarified with
the person before radiotherapy begins, as the exercises should have been well established
before starting treatment. The committee recommended that this should also happen
before surgery.

The committee were aware that instructions on upper limb exercises are not always given
out by someone who is a specialist in physiotherapy (for example, breast care nurses), so

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they also recommended that breast care units have documented local guidelines in place
that include details about who and how to deliver this information effectively. They
thought it was important that the information included details on when the exercises
should be started. For most people, this will be the day after surgery, but it may be later
for others, such as those who have certain surgical procedures (for example, free flap
reconstruction or implant reconstruction) where exercising the day after surgery could
interfere with their recovery. Exercises should be tailored to each person based on their
needs (for example, comorbidities and side effects of cancer treatment), but for the
majority of patients, a standard programme of upper limb exercises will be suitable. The
committee also agreed it was important that instructions on upper limb exercises should
be available in other formats to be accessible to people with different needs (for example,
video or large print and various languages). There are already recommendations on
communication in the NICE guideline on patient experience in adult NHS services, so a link
to this was included as part of the recommendation.

Based on the effectiveness of the intervention in the UK-based trial, the committee agreed
that people who met the same criteria as those included in the trial should be identified as
being at higher risk of developing shoulder problems. These people should then be offered
supervised support to apply the exercises. The baseline shoulder identification of
someone as high risk of developing shoulder problems could be done by a member of the
clinical team (for example, a clinical nurse specialist) and could be done by looking at a
person's medical history and asking the person if they have experienced any of the issues
listed in the recommendation (for example, asking if they have stiffness of their shoulder
or if the function of their shoulder is reduced). The evidence did not specify that these risk
factors were only relevant to the affected side and the committee noted that people
should be considered at high risk if they have any of the pre-existing shoulder conditions
in the contralateral side. It was also highlighted that for most people radiotherapy to the
axilla or supraclavicular nodes is decided before surgery. However, for some people this
may be decided after postoperative pathology review. For this reason, they recommended
that people who are identified as needing radiotherapy to the axilla or supraclavicular
nodes after surgery should also be considered as being at higher risk of developing
shoulder problems. This ensures that people would not miss out from supervised support
if the need for radiotherapy was not identified before surgery.

The committee also agreed that, in their experience, other people having surgery for
breast cancer who did not meet the high-risk criteria in the recommendations could
benefit from supervised support. This includes, for example, people with learning or
sensory disabilities, which could adversely affect their ability to carry out exercises

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without supervision and make them more likely to develop shoulder problems as a result. It
also includes people having breast cancer surgery who have side effects from additional
cancer treatments or who have other commonly performed adjunct surgeries in addition to
breast cancer surgery, as well as people who are having radiotherapy without surgery.

Based on their experience, the committee recommended that supervised support should
be delivered by a physiotherapy staff member or other appropriately trained allied health
professional (for example, an occupational therapist). This should include checking the
performance of the exercises and correcting them as needed. The committee agreed that
people may not feel confident in translating written exercise instructions into physical
movement, so would benefit from having advice on whether they are doing them correctly.
This support also allows people who might be experiencing difficulties with both the
exercises and with shoulder function to be identified early after radiotherapy or surgery. It
will also ensure that people are able to receive the full benefit from the exercises, and may
increase adherence if someone is confident they are doing the exercises correctly.

The committee also agreed supervised exercises and physiotherapy support should be
available in different formats (for example, virtual or group sessions), and be tailored to
individual circumstances and needs (for example, mental health and learning needs) to
help with adherence. There was no evidence about interventions delivered virtually, but
the committee agreed to recommend this option as it may help to reduce health
inequalities and address access options for people where other interventions are not
locally available. The committee were aware that some people may not be able to access
virtual services for a range of reasons, such as a lack of access to suitable devices, living
in areas of poor connectivity and difficulties with using the technology. However, including
virtual services in the recommendations should not provide barriers to these people
accessing support, as they can be given the option of face-to-face sessions. The
committee also highlighted that face-to-face physiotherapy may be more beneficial for
people with complex needs or those at higher risk (for example, people from minority
ethnic family backgrounds, people with disabilities, neurodiverse people, those who
experience physical difficulties with recovery or rehabilitation) because they might need
specific instructions and feedback.

The committee were mindful that, while their experience shows that virtual interventions
are beneficial, there is a lack of evidence for this and that there was no evidence on
whether the format of the intervention (individual, group, virtual, and face to face)
impacted adherence or satisfaction. Therefore, the committee took this into account when
making recommendations for research to cover this gap in the evidence.

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There was limited, low-quality evidence on long-term outcomes and no evidence on

outcomes for different population subgroups, such as people from minority ethnic family
backgrounds, disabled people and neurodiverse people. The committee also noted that
lower-quality evidence comparing interventions was not conclusive. The committee
discussed the importance of understanding the most effective and cost-effective way of
delivering the intervention (for example, type of physiotherapy or exercise, mode of
delivery, number of sessions) and the acceptability of such intervention for different
populations, and made a recommendation for research on the most effective and cost-
effective way of delivering the intervention to address this gap in the evidence.

The committee also recommended that people should be referred to the physiotherapy
department if they report a persistent reduction in arm and shoulder mobility after breast
cancer treatment. This allows people to continue to seek support if it is needed. The
committee noted that the recommendation for research into adherence to, and
satisfaction with, different intervention formats will gather evidence about the long-term
effects of strategies to reduce arm and shoulder problems, and this may reduce the
number of people who have to be referred to the physiotherapy department in future.

How the recommendations might affect practice

There may be an increase in the number of people having supervised exercise or
physiotherapy support after breast cancer surgery or before radiotherapy. However, if this
could be delivered virtually (individual or group), it is likely to have a lower impact on NHS
resources than in-person 1-to-1 sessions and could free up resources for face-to-face
interventions for those for whom virtual services are not appropriate or if there are barriers
to them accessing virtual services.

Return to recommendations

Lifestyle
Recommendations 1.14.1 and 1.14.2

Why the committee made the recommendations

There was evidence that both dietary changes (reducing fat intake and maintaining a
healthy weight) and physical activity increase survival in people with invasive breast

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cancer.

There was some evidence that cancer recurrence is more likely in people who drink more
than 3 or 4 alcoholic drinks per week or 6 g of alcohol per day. This equates to
approximately 5 units of alcohol per week.

There was no evidence that smoking cessation reduces recurrence of breast cancer,
although the view of the committee was that smoking cessation should always be
recommended to people with breast cancer.

How the recommendations might affect practice

The committee discussed that many NHS services would already be advising people with
breast cancer about the importance of a healthy lifestyle, and how they can make lifestyle
changes to reduce the risk of recurrence. The committee agreed that these
recommendations will help to direct conversations towards effective lifestyle changes.
There will be no impact on resources because these discussions were already happening,
and most of the lifestyle changes will be 'self-care' and implemented by patients
themselves.

Return to recommendations

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Context
This guideline updates and replaces the NICE guideline on early and locally advanced
breast cancer (CG80). This is because new evidence was identified in surveillance that
could affect recommendations, and has already changed clinical practice in some
locations.

People with symptoms that could be caused by breast cancer are referred by their GP to
designated breast clinics in local hospitals (see NICE's guideline on suspected cancer:
recognition and referral). In addition, eligible women are invited for screening through the
NHS Breast Screening Programme (NHSBSP) in England or the Breast Test Wales
Screening Programme (BTWSP) in Wales. For most people, whether they are referred
following breast screening or after presentation to a GP, diagnosis in the breast clinic is
made by triple assessment (clinical assessment, mammography and/or ultrasound
imaging, and core biopsy and/or fine-needle aspiration cytology). It is best practice to
carry out these assessments at the same visit (see NICE's cancer service guideline on
improving outcomes in breast cancer).

Breast cancer is the most common cancer in the UK, with approximately 54,000 new
cases of invasive disease and around 7,000 new cases of pre-invasive (in situ) disease
diagnosed annually. Most of the breast cancers occur in women, but just over 300 men in
the UK are also diagnosed with invasive breast cancer every year.

Most breast cancers are diagnosed at an early stage and are therefore potentially curable
with modern treatments. Survival rates have improved over recent decades with almost
90% of women diagnosed with breast cancer surviving their disease for 5 or more years
after diagnosis. Survival is, however, linked to the stage of the disease at diagnosis; only
15% of women diagnosed with stage IV disease are alive at 5 years. Breast cancer remains
the leading cause of death in women aged 35 to 49 years and is second only to lung
cancer as the leading cause of cancer death in all women.

The main risk factor for breast cancer is being female; the disease is 100 times less
common in men. It is also a disease of ageing, with the risk of breast cancer increasing
with increasing age. Some breast cancers are linked to lifestyle factors that include
obesity, alcohol intake and use of hormone replacement therapy, whereas other lifestyle
factors, including physical activity and breastfeeding, protect against breast cancer. About
5% of breast cancers are because of inherited mutations in high-risk genes such as

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Early and locally advanced breast cancer: diagnosis and management (NG101)

BRCA1/2 and p53.

Groups that are covered

Adults (18 and over) with:

• newly diagnosed invasive adenocarcinoma of the breast of any size (T1 to T4), with or
without spread to locoregional lymph nodes (N0 to N3) and with no distant
metastases (M0)

• newly diagnosed ductal carcinoma in situ (DCIS)

• Paget's disease of the breast.

Groups that are not covered

Adults (18 and over) with:

• invasive adenocarcinoma of the breast and distant metastases (clinical or pathological

M1)

• rare breast tumours (for example, angiosarcoma or lymphoma)

• benign breast tumours (for example, fibroadenoma)

• phyllodes tumour

• locally recurrent breast cancer or DCIS

• lobular carcinoma in situ (LCIS)

• no personal history of breast cancer and an increased risk of breast cancer due to
family history.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Finding more information and committee

details
To find NICE guidance on related topics, including guidance in development, see the NICE
topic page on breast cancer.

For full details of the evidence and the guideline committee's discussions, see the
evidence reviews. You can also find information about how the guideline was developed,
including details of the committee.

NICE has produced tools and resources to help you put this guideline into practice. For
general help and advice on putting our guidelines into practice, see resources to help you
put guidance into practice.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

Update information
June 2023: We have reviewed the evidence and made new recommendations and
recommendations for research on dose fractionation for external beam radiotherapy.
These recommendations are marked [2023].

We have also made some changes without an evidence review:

• We have updated some wording to bring the language and style up to date, without
changing the meaning.

• We have updated some recommendations to bring them in line with current

terminology and practice.

• We have combined, clarified or reworded some recommendations to make them

clearer and to improve ease of reading.

These recommendations are marked [2008, amended 2023] and [2018, amended 2023].

Recommendations marked [2009], [2017], [2018] and [2009, amended 2018] last had an
evidence review in 2009, 2017 and 2018, respectively. In some cases, minor changes have
been made to the wording to bring the language and style up to date, without changing
the meaning.

April 2023: We have reviewed the evidence and made new recommendations and
recommendations for research on arm and shoulder mobility. These recommendations are
marked [2023].

July 2018: We have reviewed the evidence and made new recommendations on the
diagnosis and treatment of people with early and locally advanced breast cancer. These
recommendations are marked [2018].

We have also made some changes without an evidence review:

• In recommendation 1.1.4, a link has been added to NICE's guideline on familial breast
cancer, which covers information on genetic testing.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

• Recommendation 1.3.3 has been amended because all recurrence rates should be
audited, not just for ductal carcinoma in situ (DCIS).

• Recommendation 1.4.6 was partly updated and replaced; the remaining part on biopsy
has been retained.

• 'Multidisciplinary team' was added to recommendation 1.6.7 to make it clear this is

where the results should be discussed.

• Recommendation 1.7.2 was amended because the original recommendations had not
made clear that premenopausal women (and men) should receive tamoxifen first line,
and that it should be used in low-risk postmenopausal women as well as if aromatase
inhibitors are not tolerated or contraindicated.

• Recommendation 1.8.4 was amended to distinguish between this recommendation and

the new recommendation for T1a/T1b, so it was felt necessary to add 'T1c and above'
to this recommendation. The wording of the trastuzumab recommendations have been
amended in line with the current summary of product characteristics and the
population added to make the recommendation clearer.

• Recommendation 1.9.4 was reworded to exclude those people who were receiving
bisphosphonates as adjuvant therapy.

• In recommendation 1.10.7, the word 'adequate' was changed to 'with clear margins'.

• Recommendation 1.10.9 was changed from 'offer' to 'consider' because it contradicted

the new recommendations on margins after surgery for DCIS.

• In recommendation 1.10.17, the term 'site of local excision' has been amended to
'tumour bed', and breast-conserving surgery has been removed because this is now
covered by additional recommendations.

• In recommendation 1.10.19, the term 'axilla and supraclavicular fossa' has been
changed to 'regional lymph nodes'.

• In recommendation 1.10.20, the term 'ALND' has been changed to 'axillary clearance'.

• In recommendation 1.12.17, the guideline committee was aware of new evidence on

other selective serotonin reuptake inhibitors (SSRIs) and has amended the wording
accordingly but could not be specific because there was no new evidence review in
this guideline update.

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Early and locally advanced breast cancer: diagnosis and management (NG101)

These recommendations are marked [2009, amended 2018].

Recommendations marked [2009] last had an evidence review in 2009. In some cases,
minor changes have been made to the wording to bring the language and style up to date,
without changing the meaning.

Minor changes since publication

May 2022: We added a link to NICE's guideline on medicines associated with dependence
or withdrawal symptoms in the section on menopausal symptoms.

ISBN: 978-1-4731-5248-9

Accreditation

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