Recommendations | Early and locally advanced breast cancer: diagnosis and management | Guidance

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
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]

1.2 Providing 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 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. [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 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]

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]

**Table 1 Breast reconstruction options for women who choose breast reconstruction**
Category	Immediate breast reconstruction	Delayed breast reconstruction
Definition	Reconstruction is started in the same operation as the mastectomy	After a mastectomy, reconstruction is done in a separate operation
Number and timing of operations	More than 1 operation is usually needed to complete the reconstruction The total number of operations will vary. It may be affected by factors such as: type of reconstruction (for example, some are planned in stages; a prosthesis may be worn until reconstruction is complete) personal preferences (such as whether a nipple reconstruction is requested) Fewer operations may be needed	More than 1 operation is usually needed to complete the reconstruction The total number of operations will vary. It may be affected by factors such as: type of reconstruction (for example, some are planned in stages; a prosthesis may be worn until reconstruction is complete) personal preferences (such as whether a nipple reconstruction is requested) More operations may be needed
Breast reconstruction options available	These will vary depending on personal preferences (such as breast size desired), current body shape, other health conditions, previous operations and lifestyle factors (such as hobbies) Not all hospitals or surgeons can offer all procedures. Travel to a different hospital may be needed for a specific option Options may be available that spare or preserve the breast skin (which may mean less scarring and a more natural look) Limited time to make a decision about options (which may include not having a reconstruction) before surgery	These will vary depending on personal preferences (such as breast size desired), current body shape, other health conditions, previous operations and lifestyle factors (such as hobbies) Not all hospitals or surgeons can offer all procedures. Travel to a different hospital may be needed for a specific option Certain options that spare or preserve the breast skin may not be available More time to make a decision (which may include not having a reconstruction) and to plan reconstruction
Benefits	Breast shape remains, which may help maintain body image and have subsequent psychological benefits	Lifestyle changes (such as losing weight and taking regular exercise) may be possible, which increase the options and lower the risks of reconstruction surgery Procedures (and associated recovery) can be planned around other commitments
Risks	Surgical complications can occur after any breast reconstruction and will vary by type of procedure and personal risk factors May be lower rates of: tissue breakdown surgery for flap removal if it cannot be used because of a complication (which may lead to delayed reconstruction and flat appearance for a period of time) procedures to improve symmetry Complications from the mastectomy or axillary surgery can occur during the recovery period	Surgical complications can occur after any breast reconstruction and will vary by type of procedure and personal risk factors May be lower rates of: mastectomy site complications flap or implant failure (which may lead to delayed reconstruction and flat appearance for a period of time) capsular contracture (a scar layer around the implant that may lead to pain if severe) May need to interrupt hormone therapies (tamoxifen) for further surgery
Satisfaction	No clear differences in satisfaction with completed reconstructions	No clear differences in satisfaction with completed reconstructions
Reconstruction and adjuvant therapy (including radiotherapy and chemotherapy)	Radiotherapy or chemotherapy can be given but may be delayed if there are complications from the mastectomy or reconstruction Immediate reconstructions using implants may be more affected by radiotherapy than immediate flap reconstructions May need adaptions to scans if a tissue expander is used. For example, may not be able to have MRI scans and may need modified radiotherapy planning	Complications can also occur after mastectomy alone, which may delay chemotherapy or radiotherapy

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 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:

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, 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, 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**
Category	Extended tamoxifen therapy (after an initial 5 years of tamoxifen therapy)	Extended endocrine therapy with an aromatase inhibitor (after 5 years of tamoxifen therapy)
Definition	Continuing to take tamoxifen after 5 years of tamoxifen therapy	Switching to an aromatase inhibitor after 5 years of tamoxifen therapy
Who can take this therapy	People with ER-positive invasive breast cancer	Postmenopausal women with ER-positive invasive breast cancer
Effect on breast cancer recurrence: The benefit for an individual person will depend on the risk of their cancer returning. For people with a low risk of recurrence, the benefits may not outweigh the risks or side effects Medium or high risk may include people who have lymph node-positive breast cancer, with tumours that are T2 or greater and higher grade. Low risk may include people with lymph node-negative breast cancer, with smaller or lower-grade tumours	Evidence shows lower rates of breast cancer recurrence compared with 5 years of tamoxifen therapy in women	Lower rates of breast cancer recurrence compared with 5 years of tamoxifen therapy In postmenopausal women, switching to an aromatase inhibitor may be more effective at reducing recurrence than continuing with tamoxifen
Side effects: These are common side effects experienced during additional years taking endocrine therapy. Most effects are reversible when tablets are stopped	Side effects of endocrine therapy will continue for additional years (for example, menopausal symptoms such as hot flushes) Side effects may differ in men With extended use of tamoxifen: increased risk of thrombosis and endometrial cancer, and possibly bone density loss in premenopausal women	Side effects of endocrine therapy will continue for additional years (for example, menopausal symptoms such as hot flushes) With extended use of aromatase inhibitors: bone density loss, and joint and muscle pain
Fertility and family planning	For women, effects on fertility and family planning will continue for additional years as they should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby	Not applicable as postmenopausal women only

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**
Category	Endocrine therapy after breast-conserving surgery for women with ER-positive DCIS
Definition	Tamoxifen or an aromatase inhibitor for 5 years, taken as a once-daily tablet
Effect on survival and disease recurrence: The benefit for an individual person will depend on the risk of their cancer returning. For people with low risk of recurrence, the benefits may not outweigh the risks or side effects Risk can be estimated using a range of standardised tools and clinical expertise	No effect on survival at 5 or 10 years after diagnosis Lower rate of recurrence of DCIS and lower rate of invasive breast cancer, compared with women who did not receive endocrine therapy or radiotherapy after surgery
Side effects	All endocrine therapies: menopausal symptoms, such as hot flushes For tamoxifen: increased risk of thrombosis, endometrial cancer and possibly bone density loss in premenopausal women For aromatase inhibitors: joint and muscle pain, urogenital symptoms and bone density loss
Fertility and family planning	Effects on fertility and family planning as women should not become pregnant while 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 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 anthracycline-containing regimen	3‑weekly docetaxel	Weekly or fortnightly paclitaxel
Effect on survival: The benefit for an individual person will depend on the risk of their cancer returning. For people with low risk of recurrence, the benefits may not outweigh the risks or side effects	Some evidence for improved outcomes, including reducing the risk of breast cancer returning and increasing the chance of surviving	Some evidence for improved outcomes, including reducing the risk of breast cancer returning and increasing the chance of surviving
Benefits	Smaller doses of anthracyclines can be used, which can reduce the risk of side effects such as nausea and vomiting Smaller cumulative doses of individual drugs may reduce long-term side effects, for example, cardiac toxicity and risk of second malignancies	Smaller doses of anthracyclines can be used, which can reduce the risk of side effects such as nausea and vomiting Smaller cumulative doses of individual drugs may reduce long-term side effects, for example, cardiac toxicity and risk of second malignancies
Side effects	Additional side effects may include joint and muscle pain, nerve damage, higher rates of febrile neutropenia and hypersensitivity reactions Some people have long-term hair loss (alopecia) after treatment with taxanes	Additional side effects may include nerve damage and hypersensitivity reactions, but febrile neutropenia is less likely than with 3‑weekly docetaxel Some people have long-term hair loss (alopecia) after treatment with taxanes Weekly paclitaxel is tolerated best, but even fortnightly is better tolerated than 3‑weekly docetaxel
Administration	Visits to hospital every 3 weeks	Visits to hospital every week or every 2 weeks
Length of course	9 to 12 weeks (3 to 4 cycles)	8 to 12 weeks

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
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]

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]

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:

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
Effect on local recurrence	On average, in 1,000 women, over 5 years local recurrence occurs in about 10 women, and does not occur in about 990 women	On average, in 1,000 women, over 5 years local recurrence occurs in about 50 women, and does not occur in about 950 women
Effect on survival	No difference in overall survival at 10 years	No difference in overall survival at 10 years
Risks	Possibility of short- and long-term adverse effects on the breast, and resulting cosmetic changes (such as skin soreness, changes to colour of skin, radiation fibrosis or stiffening of the breast tissue)	No short- or long-term adverse effects on the breast, or cosmetic changes
Side effects	In this group of women at low risk, there is no increase in serious late side effects of radiotherapy (such as congestive cardiac failure, myocardial infarction or secondary cancer)	No side effects of radiotherapy will occur
Administration	Given at the treatment centre 5 days a week for 3 weeks after surgery	No need to attend the treatment centre for 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]

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:

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 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 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]

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**
Category	Effect of adding a platinum to anthracycline-containing (with or without taxane) neoadjuvant chemotherapy
Effect on breast conservation rate	Adding a platinum improves response rates compared with anthracycline-based (with or without taxane) chemotherapy. This may mean that some women who would otherwise need a mastectomy can be offered breast-conserving surgery
Effect on pathological complete response rate (no residual cancer found at surgery)	Adding a platinum improves the chances of all signs of cancer disappearing in both the breast and lymph nodes in the axilla, compared with anthracycline-based (with or without taxane) neoadjuvant chemotherapy
Effect on survival	No increase in overall survival with platinum-based chemotherapy
Side effects: Platinum-based therapy is only suitable for fit patients with no significant comorbidities	Adding a platinum may mean that side effects are more severe. Anaemia, thrombocytopenia, neutropenia and febrile neutropenia are seen more frequently with platinum-based chemotherapy On average, if 1,000 women with triple-negative breast cancer receive platinum-containing neoadjuvant chemotherapy, about 70 additional women would experience severe or life-threatening side effects compared with non-platinum neoadjuvant chemotherapy 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]

**Table 7 Benefits and risks of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy for women with ER-positive/HER2-negative breast cancer**
Category	Neoadjuvant endocrine therapy	Neoadjuvant chemotherapy
Definition	Tamoxifen or an aromatase inhibitor started before surgery Only an option for women with ER-positive breast cancer	Chemotherapy given before surgery Only an option for people who would be recommended adjuvant (after surgery) chemotherapy
Administration	Tablet taken once a day at home	Intravenous administration in hospital, as an outpatient
Effectiveness	For postmenopausal women: may be as effective as neoadjuvant chemotherapy in terms of breast conservation rates and shrinking the tumour For premenopausal women: less effective than neoadjuvant chemotherapy at shrinking the tumour (but some tumours may respond so may be effective in some women)	For postmenopausal women: effective at improving breast conservation rates and shrinking the tumour For premenopausal women: more effective than endocrine therapy at shrinking the tumour
Potential disadvantages	If neoadjuvant endocrine therapy is not effective, then women may proceed to surgery earlier or may still need to have chemotherapy, either before or after surgery	–
Side effects	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, urogenital symptoms, bone density loss (may also occur with tamoxifen in premenopausal women) Side effects are usually reversible May allow women to avoid the additional side effects of chemotherapy (although women may still need adjuvant chemotherapy after surgery)	Side effects may include nausea and vomiting, risk of infections that may be life threatening, fatigue, neuropathy, cardiac toxicity, diarrhoea, constipation, sore mouth, skin and nail changes, risk of blood clots, risk of second malignancies, fluid retention, allergic reactions and hair loss Side effects may persist long term
Fertility and family planning	Women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby	Often causes temporary infertility May cause permanent infertility
Length of course	May take longer than chemotherapy to shrink the tumour enough for breast-conserving surgery	The duration of neoadjuvant chemotherapy is shorter than neoadjuvant endocrine therapy

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]

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]

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
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:

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]

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 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
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.