- 1.1 Referral, diagnosis and preoperative assessment
- 1.2 Providing information and psychological support
- 1.3 Surgery to the breast
- 1.4 Surgery to the axilla
- 1.5 Breast reconstruction
- 1.6 Postoperative assessment and adjuvant therapy planning
- 1.7 Endocrine therapy
- 1.8 Chemotherapy
- 1.9 Biological therapy
- 1.10 Assessment and treatment of bone loss
- 1.11 Radiotherapy
- 1.12 Primary systemic therapy
- 1.13 Complications of local treatment and menopausal symptoms
- 1.14 Follow-up
- More information
The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.
Patients 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, women aged between 50 and 70 are invited for screening mammography every 3 years through the NHS Breast Screening Programme (NHSBSP) in England or the Breast Test Wales Screening Programme (BTWSP) in Wales. For most patients, 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 cancer service guidance 'Improving outcomes in breast cancer – Manual update').
Preoperative assessment of the breast and axilla
1.1.1 The routine use of magnetic resonance imaging (MRI) of the breast is not recommended in the preoperative assessment of patients with biopsy-proven invasive breast cancer or ductal carcinoma in situ (DCIS).
1.1.2 Offer MRI of the breast to patients with invasive breast cancer:
if there is discrepancy regarding the extent of disease from clinical examination, mammography and ultrasound assessment for planning treatment
if breast density precludes accurate mammographic assessment
to assess the tumour size if breast conserving surgery is being considered for invasive lobular cancer.
Preoperative staging of the axilla
1.1.3 Pretreatment ultrasound evaluation of the axilla should be performed for all patients being investigated for early invasive breast cancer and, if morphologically abnormal lymph nodes are identified, ultrasound-guided needle sampling should be offered.
1.2.1 All members of the breast cancer clinical team should have completed an accredited communication skills training programme.
1.2.2 All patients with breast cancer should be assigned to a named breast care nurse specialist who will support them throughout diagnosis, treatment and follow-up.
1.2.3 All patients with breast cancer should be offered prompt access to specialist psychological support, and, where appropriate, psychiatric services.
1.3.1 For all patients treated with breast conserving surgery for DCIS a minimum of 2 mm radial margin of excision is recommended with pathological examination to NHSBSP reporting standards. Re-excision should be considered if the margin is less than 2 mm, after discussion of the risks and benefits with the patient.
1.3.2 Enter patients with screen-detected DCIS into the Sloane Project (UK DCIS audit).
1.3.3 All breast units should audit their recurrence rates after treatment for DCIS.
1.3.4 Offer breast conserving surgery with removal of the nipple-areolar complex as an alternative to mastectomy for patients with Paget's disease of the nipple that has been assessed as localised. Offer oncoplastic repair techniques to maximise cosmesis.
Invasive breast cancer
1.4.1 Minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer and no evidence of lymph node involvement on ultrasound or a negative ultrasound-guided needle biopsy. Sentinel lymph node biopsy (SLNB) is the preferred technique.
1.4.2 SLNB should only be performed by a team that is validated in the use of the technique, as identified in the New Start training programme.
1.4.3 Perform SLNB using the dual technique with isotope and blue dye.
1.4.4 Breast units should audit their axillary recurrence rates.
1.4.5 Do not perform SLNB routinely in patients with a preoperative diagnosis of DCIS who are having breast conserving surgery, unless they are considered to be at a high risk of invasive disease.
1.4.6 Offer SLNB to all patients who are having a mastectomy for DCIS.
Evaluation and management of a positive sentinel lymph node
1.4.7 Offer further axillary treatment to patients with early invasive breast cancer who:
have macrometastases or micrometastases shown in a sentinel lymph node
have a preoperative ultrasound-guided needle biopsy with histologically proven metastatic cancer.
The preferred technique is axillary lymph node dissection (ALND) because it gives additional staging information.
1.4.8 Do not offer further axillary treatment to patients found to have only isolated tumour cells in their sentinel lymph nodes. These patients should be regarded as lymph node-negative.
1.5.1 Discuss immediate breast reconstruction with all patients who are being advised to have a mastectomy, and offer it except where significant comorbidity or (the need for) adjuvant therapy may preclude this option. All appropriate breast reconstruction options should be offered and discussed with patients, irrespective of whether they are all available locally.
1.6.1 Assess oestrogen receptor (ER) status of all invasive breast cancers, using immunohistochemistry with a standardised and qualitatively assured methodology, and report the results quantitatively.
1.6.2 Do not routinely assess progesterone receptor status of tumours in patients with invasive breast cancer.
1.6.3 Test human epidermal growth receptor 2 (HER2) status of all invasive breast cancers, using a standardised and qualitatively assured methodology.
1.6.4 Ensure that the results of ER and HER2 assessments are available and recorded at the multidisciplinary team meeting when guidance about systemic treatment is made.
Adjuvant therapy planning
1.6.5 Consider adjuvant therapy for all patients with early invasive breast cancer after surgery at the multidisciplinary team meeting and ensure that decisions are recorded.
1.6.6 Decisions about adjuvant therapy should be made based on assessment of the prognostic and predictive factors, the potential benefits and side effects of the treatment. Decisions should be made following discussion of these factors with the patient.
1.6.7 Consider using Adjuvant! Online to support estimations of individual prognosis and the absolute benefit of adjuvant treatment for patients with early invasive breast cancer.
1.6.8 Start adjuvant chemotherapy or radiotherapy as soon as clinically possible within 31 days of completion of surgery in patients with early breast cancer having these treatments.
1.6.9 Offer genetic testing for BRCA1 and BRCA2 mutations to women under 50 years with triple negative breast cancer, but no family history of breast or ovarian cancer. 
Ovarian suppression/ablation for early invasive breast cancer
1.7.1 Do not offer adjuvant ovarian ablation/suppression to premenopausal women with ER-positive early invasive breast cancer who are being treated with tamoxifen and, if indicated, chemotherapy.
1.7.2 Offer adjuvant ovarian ablation/suppression in addition to tamoxifen to premenopausal women with ER-positive early invasive breast cancer who have been offered chemotherapy but have chosen not to have it.
Aromatase inhibitors for early invasive breast cancer
1.7.3 Postmenopausal women with ER-positive early invasive breast cancer who are not considered to be at low risk should be offered an aromatase inhibitor, either anastrozole or letrozole, as their initial adjuvant therapy. Offer tamoxifen if an aromatase inhibitor is not tolerated or contraindicated.
1.7.4 Offer an aromatase inhibitor, either exemestane or anastrozole, instead of tamoxifen to postmenopausal women with ER-positive early invasive breast cancer who are not low risk and who have been treated with tamoxifen for 2–3 years.
1.7.5 Offer additional treatment with the aromatase inhibitor letrozole for 2–3 years to postmenopausal women with lymph node-positive ER-positive early invasive breast cancer who have been treated with tamoxifen for 5 years.
1.7.6 The aromatase inhibitors anastrozole, exemestane and letrozole, within their licensed indications, are recommended as options for the adjuvant treatment of early ER-positive invasive breast cancer in postmenopausal women.
1.7.7 The choice of treatment should be made after discussion between the responsible clinician and the woman about the risks and benefits of each option. Factors to consider when making the choice include whether the woman has received tamoxifen before, the licensed indications and side-effect profiles of the individual drugs and, in particular, the assessed risk of recurrence.
Tamoxifen for ductal carcinoma in situ
1.7.8 Do not offer adjuvant tamoxifen after breast conserving surgery to patients with DCIS.
1.8.1 Offer docetaxel to patients with lymph node-positive breast cancer as part of an adjuvant chemotherapy regimen.
1.8.2 Do not offer paclitaxel as an adjuvant treatment for lymph node-positive breast cancer.
1.9.1 Offer trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), as an adjuvant treatment to women with HER2-positive early invasive breast cancer following surgery, chemotherapy, and radiotherapy when applicable.
1.9.2 Assess cardiac function before starting treatment with trastuzumab. Do not offer trastuzumab treatment to women who have any of the following:
a left ventricular ejection fraction (LVEF) of 55% or less
a history of documented congestive heart failure
high-risk uncontrolled arrhythmias
angina pectoris requiring medication
clinically significant valvular disease
evidence of transmural infarction on electrocardiograph (ECG)
poorly controlled hypertension.
1.9.3 Repeat cardiac functional assessments every 3 months during trastuzumab treatment. If the LVEF drops by 10 percentage (ejection) points or more from baseline and to below 50% then trastuzumab treatment should be suspended. Restart trastuzumab therapy only after further cardiac assessment and a fully informed discussion of the risks and benefits with the woman.
1.10.1 Patients with early invasive breast cancer should have a baseline dual energy X-ray absorptiometry (DEXA) scan to assess bone mineral density if they:
are starting adjuvant aromatase inhibitor treatment
have treatment-induced menopause
are starting ovarian ablation/suppression therapy.
1.10.2 Do not offer a DEXA scan to patients with early invasive breast cancer who are receiving tamoxifen alone, regardless of pretreatment menopausal status.
1.10.3 Offer bisphosphonates to patients identified by algorithms 1 and 2 in 'Guidance for the management of breast cancer treatment-induced bone loss: a consensus position statement from a UK expert group' (2008) (see appendix 2 of the full guideline).
Radiotherapy after breast conserving surgery
1.11.1 Patients with early invasive breast cancer who have had breast conserving surgery with clear margins should have breast radiotherapy.
1.11.2 Offer adjuvant radiotherapy to patients with DCIS following adequate breast conserving surgery and discuss with them the potential benefits and risks (see recommendation in section 1.3.1)
Radiotherapy after mastectomy
1.11.3 Offer adjuvant chest wall radiotherapy to patients with early invasive breast cancer who have had a mastectomy and are at a high risk of local recurrence. Patients at a high risk of local recurrence include those with four or more positive axillary lymph nodes or involved resection margins.
1.11.4 Consider entering patients who have had a mastectomy for early invasive breast cancer and who are at an intermediate risk of local recurrence into the current UK trial (SUPREMO) assessing the value of postoperative radiotherapy. Patients at an intermediate risk of local recurrence include those with one to three lymph nodes involved, lymphovascular invasion, histological grade 3 tumours, ER-negative tumours, and those aged under 40.
1.11.5 Do not offer radiotherapy following mastectomy to patients with early invasive breast cancer who are at low risk of local recurrence (for example, most patients who are lymph node-negative).
1.11.6 Use external beam radiotherapy giving 40 Gy in 15 fractions as standard practice for patients with early invasive breast cancer after breast conserving surgery or mastectomy.
1.11.7 Offer an external beam boost to the site of local excision to patients with early invasive breast cancer and a high risk of local recurrence, following breast conserving surgery with clear margins and whole breast radiotherapy.
1.11.8 If an external beam boost to the site of local excision following breast conserving surgery is being considered in patients with early invasive breast cancer, inform the patient of the side effects associated with this intervention, including poor cosmesis, particularly in women with larger breasts.
Radiotherapy to nodal areas
1.11.9 Do not offer adjuvant radiotherapy to the axilla or supraclavicular fossa to patients with early breast cancer who have been shown to be histologically lymph node-negative.
1.11.10 Do not offer adjuvant radiotherapy to the axilla after ALND for early breast cancer.
1.11.11 If ALND is not possible following a positive axillary SLNB or four-node sample, offer adjuvant radiotherapy to the axilla to patients with early breast cancer (see recommendations in sections 1.4.1 and 1.4.7).
1.11.12 Offer adjuvant radiotherapy to the supraclavicular fossa to patients with early breast cancer and four or more involved axillary lymph nodes.
1.11.13 Offer adjuvant radiotherapy to the supraclavicular fossa to patients with early breast cancer and one to three positive lymph nodes if they have other poor prognostic factors (for example, T3 and/or histological grade 3 tumours) and good performance status.
1.11.14 Do not offer adjuvant radiotherapy to the internal mammary chain to patients with early breast cancer who have had breast surgery.
Early breast cancer
1.12.1 Treat patients with early invasive breast cancer, irrespective of age, with surgery and appropriate systemic therapy, rather than endocrine therapy alone, unless significant comorbidity precludes surgery.
1.12.2 Preoperative systemic therapy can be offered to patients with early invasive breast cancer who are considering breast conserving surgery that is not advisable at presentation. However, the increased risk of local recurrence with breast conserving surgery and radiotherapy rather than mastectomy after systemic therapy should be discussed with the patient.
Locally advanced or inflammatory breast cancer
1.12.3 Offer local treatment by mastectomy (or, in exceptional cases, breast conserving surgery) followed by radiotherapy to patients with locally advanced or inflammatory breast cancer who have been treated with chemotherapy.
1.13.1 Inform all patients with early breast cancer about the risk of developing lymphoedema and give them relevant written information before treatment with surgery and radiotherapy.
1.13.2 Give advice on how to prevent infection or trauma that may cause or exacerbate lymphoedema to patients treated for early breast cancer.
1.13.3 Ensure that all patients with early breast cancer who develop lymphoedema have rapid access to a specialist lymphoedema service.
1.13.4 All breast units should have written local guidelines agreed with the physiotherapy department for postoperative physiotherapy regimens.
1.13.5 Identify breast cancer patients with pre-existing shoulder conditions preoperatively as this may inform further decisions on treatment.
1.13.6 Give instructions on functional exercises, which should start the day after surgery, to all breast cancer patients undergoing axillary surgery. This should include relevant written information from a member of the breast or physiotherapy team.
1.13.7 Refer patients to the physiotherapy department if they report a persistent reduction in arm and shoulder mobility after breast cancer treatment.
1.13.8 Discontinue hormone replacement therapy (HRT) in women who are diagnosed with breast cancer.
1.13.9 Do not offer HRT (including oestrogen/progestogen combination) routinely to women with menopausal symptoms and a history of breast cancer. HRT may, in exceptional cases, be offered to women with severe menopausal symptoms and with whom the associated risks have been discussed.
1.13.10 Offer information and counselling for all women about the possibility of early menopause and menopausal symptoms associated with breast cancer treatment.
1.13.11 Tibolone or progestogens are not recommended for women with menopausal symptoms who have breast cancer.
1.13.12 The selective serotonin re-uptake inhibitor antidepressants paroxetine and fluoxetine may be offered to women with breast cancer for relieving menopausal symptoms, particularly hot flushes, but not to those taking tamoxifen.
1.13.14 Soy (isoflavone), red clover, black cohosh, vitamin E and magnetic devices are not recommended for the treatment of menopausal symptoms in women with breast cancer.
1.14.1 Offer annual mammography to all patients with early breast cancer, including DCIS, until they enter the NHSBSP/BTWSP. Patients diagnosed with early breast cancer who are already eligible for screening should have annual mammography for 5 years.
1.14.2 On reaching the NHSBSP/BTWSP screening age or after 5 years of annual mammography follow-up we recommend the NHSBSP/BTWSP stratify screening frequency in line with patient risk category.
1.14.3 Do not offer mammography of the ipsilateral soft tissues after mastectomy.
1.14.4 Do not offer ultrasound or MRI for routine post-treatment surveillance in patients who have been treated for early invasive breast cancer or DCIS.
1.14.5 After completion of adjuvant treatment (including chemotherapy, and/or radiotherapy where indicated) for early breast cancer, discuss with patients where they would like follow-up to be undertaken. They may choose to receive follow-up care in primary, secondary, or shared care.
1.14.6 Patients treated for breast cancer should have an agreed, written care plan, which should be recorded by a named healthcare professional (or professionals), a copy sent to the GP and a personal copy given to the patient. This plan should include:
designated named healthcare professionals
dates for review of any adjuvant therapy
details of surveillance mammography
signs and symptoms to look for and seek advice on
contact details for immediate referral to specialist care, and
contact details for support services, for example support for patients with lymphoedema.
You can also see this guideline in the NICE pathway on early and locally advanced breast cancer.
To find out what NICE has said on topics related to this guideline, see our web page on cancer.
 NEW START Sentinel Lymph Node Biopsy Training Programme, The Royal College of Surgeons of England.
 Patients considered at high risk of invasive disease include those with a palpable mass or extensive microcalcifications.
 Department of Health (2007) Cancer reform strategy. London: Department of Health. (At present no equivalent target has been set by the Welsh Assembly Government.)
 Low-risk patients are those in the EPG or GPG (excellent prognostic group or good prognostic group) in the Nottingham Prognostic Index (NPI), who have 10-year predictive survivals of 96% and 93%, respectively. They would have a similar prediction using Adjuvant! Online.
 This recommendation is from 'Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer' (NICE technology appraisal guidance 112).
 Reid DM, Doughty J, Eastell R et al (2008) Guidance for the management of breast cancer treatment-induced bone loss: a consensus position statement from a UK Expert Group. Cancer Treatment Reviews 34: S3–S18.
 The summaries of product characteristics state that HRT is contraindicated in women with known, past or suspected breast cancer. Informed consent should be obtained and documented.
 These drugs are not licensed for the stated use. Informed consent should be obtained and documented.