Quick reference guide Early and locally advanced breast cancer
This guideline updates and replaces NICE technology appraisal guidance 109 (docetaxel), 108 (paclitaxel) and 107 (trastuzumab)
NICE clinical guideline 80Developed by the National Collaborating Centre for Cancer
Early and locally advanced breast cancer About this booklet This is a quick reference guide that summarises the recommendations NICE has made to the NHS in ‘Early and locally advanced breast cancer: diagnosis and treatment’ (NICE clinical guideline 80). The guideline updates and replaces NICE technology appraisal guidance 109 (published September 2006), 108 (published September 2006) and 107 (published August 2006). Who should read this booklet? This quick reference guide is for healthcare professionals and other staff who care for patients with early and locally advanced breast cancer. Who wrote the guideline? The guideline was developed by the National Collaborating Centre for Cancer, which is based at the Velindre NHS Trust in Cardiff. The Collaborating Centre worked with a group of healthcare professionals (including consultants, GPs and nurses), patients and carers, and technical staff, who reviewed the evidence and drafted the recommendations. The recommendations were finalised after public consultation.
For more information on how NICE clinical guidelines are developed, go to www.nice.org.uk
Where can I get more information about the guideline? The NICE website has the recommendations in full, reviews of the evidence they are based on, a summary of the guideline for patients and carers, and tools to support implementation (see page 18 for more details). National Institute for Health and Clinical Excellence
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NICE clinical guidelines are recommendations about the treatment and care of people with specificdiseases and conditions in the NHS in England and Wales.
This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account whenexercising their clinical judgement. However, the guidance does not override the individualresponsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance,in their local context, in light of their duties to avoid unlawful discrimination and to have regard topromoting equality of opportunity. Nothing in this guidance should be interpreted in a way thatwould be inconsistent with compliance with those duties. Early and locally advanced breast cancer Contents Introduction Patient-centred care Key priorities for implementation Abbreviations used in this booklet Overview of care pathway Information and psychological support Assessment of the breast Assessment of the axilla Postoperative assessment Systemic therapy Adjuvant therapy planning Adjuvant therapy Complications of local treatment and menopausal symptoms Follow-up care Further information Implementation tools NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Introduction ● Breast cancer is the most common cancer affecting women in England and Wales, with about
40,500 new cases diagnosed and 10,900 deaths recorded in England and Wales each year1, 2.
● In men breast cancer is rare, with about 260 cases diagnosed and 68 deaths in England and
● Of these new cases, a small proportion are diagnosed in the advanced stages, when the tumour
has spread significantly within the breast or to other organs of the body.
● In addition, a significant number of women who have been previously treated with curative
intent subsequently develop either a local recurrence or metastases.
● Early breast cancer is subdivided into two major categories: in situ ductal disease and
● Over recent years there have been important developments in the investigation and management
of breast cancer, including new chemotherapies and biological and hormonal agents.
● This clinical guideline helps to address practice variation across the country and inconsistent
availability of certain treatments and procedures, and offers guidance on best practice.
● The guideline recommends some drugs for indications for which they do not have a UK
marketing authorisation at the date of publication, as there is good evidence to support that use. Unlicensed drugs are marked with a footnote.
Patient-centred care Treatment and care should take into account patients’ individual needs and preferences. Good communication is essential, supported by evidence-based information, to allow patients to reach informed decisions about their care. Follow Department of Health advice on seeking consent if needed. If the patient agrees, families and carers should have the opportunity to be involved in decisions about treatment and care.
1 Office for National Statistics (2008) Cancer statistics registrations: registrations of cancer diagnosed in 2005, England. Series MB1 number 36. London: Office for National Statistics. 2 Welsh Cancer Intelligence and Surveillance Unit (2008) Cancer incidence in Wales 1992−2002. Cardiff: Welsh CancerIntelligence and Surveillance Unit. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Key priorities for implementation Preoperative assessment of the breast ● Offer magnetic resonance imaging (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
Staging of the axilla ● 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 areidentified, ultrasound-guided needle sampling should be offered.
Surgery to the axilla ● 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 onultrasound or a negative ultrasound-guided needle biopsy. Sentinel lymph node biopsy is thepreferred technique.
Breast reconstruction ● 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 therapymay preclude this option. All appropriate breast reconstruction options should be offered anddiscussed with patients, irrespective of whether they are all available locally.
Adjuvant therapy planning ● Start adjuvant chemotherapy or radiotherapy as soon as clinically possible within 31 days of
completion of surgery3 in patients with early breast cancer having these treatments.
Aromatase inhibitors ● Postmenopausal women with oestrogen receptor-positive early invasive breast cancer who are
not considered to be at low risk4 should be offered an aromatase inhibitor, either anastrozole orletrozole, as their initial adjuvant therapy. Offer tamoxifen if an aromatase inhibitor iscontraindicated or not tolerated.
3 Department of Health (2007). Cancer reform strategy. London: Department of Health. (At present no equivalent target hasbeen set by the Welsh Assembly Government.)4 Low-risk patients are those in the EPG or GPG (excellent or good prognostic group) in the Nottingham Prognostic Index (NPI), who have 10-year predictive survivals of 96% and 93%, respectively. They would have similar predictions using Adjuvant! Online.
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Key priorities for implementation continued Assessment of bone loss ● 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.
Primary systemic therapy ● 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.
Follow-up imaging ● Offer annual mammography to all patients with early breast cancer, including ductal carcinoma
in situ, until they enter the NHS Breast Screening Programme/Breast Test Wales ScreeningProgramme. Patients diagnosed with early breast cancer who are already eligible for screeningshould have annual mammography for 5 years.
Clinical follow-up ● 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 apersonal 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.
Abbreviations used in this booklet NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Overview of care pathway (coloured boxes denote areas addressed in the guideline)
a May include repeat core biopsy, open biopsy or MRI. b Some patients may not require staging. c Surgery may not be appropriate for all patients and for some patients primary systemic therapy precedes surgery.
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Information and psychological support
● All members of the breast cancer clinical team should have completed an accredited
communications skills training programme.
● All patients with breast cancer should:
− be assigned to a named breast care nurse specialist who will support them throughout
− be offered prompt access to specialist psychological support and, where appropriate,
Assessment of the breast
● Routine MRI of the breast is not recommended for patients with biopsy-proven invasive breast
● Offer MRI of the breast to patients with invasive breast cancer:
– if there is discrepancy between the clinical and imaging assessment of disease extent – if breast density precludes accurate mammographic assessment– to assess tumour size if breast conserving surgery is being considered for invasive lobular cancer. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Assessment of the axilla Patients with DCIS Patient group
not considered at high risk of invasive disease. Patients at high risk include those with a palpable mass or extensive microcalcifications
Patients with early invasive breast cancer Patient group
● Perform pretreatment ultrasound evaluation of the axilla. ● If morphologically abnormal lymph nodes are identified, offer
● Perform minimal surgery, rather than lymph node clearance.
● SLNB should only be performed by a team that is validated in
the use of the technique, as identified in the NEW START training programme5.
● Perform SLNB using the dual technique with isotope and
● Offer further axillary treatment. Axillary lymph node dissection
(ALND) is the preferred technique because it gives additional
● Do not offer further axillary treatment. Regard as lymph
● Breast units should audit their axillary recurrence rates.
5 NEW START Sentinel Lymph Node Biopsy Training Programme, Royal College of Surgeons of England(www.rcseng.ac.uk/education/courses/new_start.html)
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Patients with DCIS Patient group
● A minimum of 2mm radial margin of excision is recommended,
with pathological examination to NHSBSP reporting standards.
● Consider re-excision if margin < 2mm after discussion of risks
● Enter patients into the Sloane Project (UK DCIS audit)
● Breast units should audit their recurrence rates. Patients with Paget’s disease of the nipple Patient group
● Offer breast conserving surgery with removal of the
nipple–areolar complex as an alternative to mastectomy.
● Offer oncoplastic repair techniques to maximise cosmesis. Patients advised to have mastectomy Patient group
● Discuss immediate breast reconstruction, except where
comorbidities or adjuvant therapy may preclude this option.
● Offer and discuss all breast reconstruction options with
patients, irrespective of whether they are all available locally. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Postoperative assessment All patients with early invasive breast cancer ● Use standardised and qualitatively assured methodologies to assess ER and HER2 status.
● Assess ER status using immunohistochemistry and report the result quantitatively.
● Ensure results of ER and HER2 status assessment are available and recorded at the MDT meeting
at which guidance about systemic treatment is made.
● Do not routinely assess progesterone receptor status.
Systemic therapy Patients with early invasive breast cancer Patient group
● Treat with surgery followed by adjuvant systemic therapy
(rather than with endocrine therapy alone) unless significantcomorbidity prevents surgery.
● Preoperative systemic therapy can be offered.
● Discuss with the patient the increased risk of local recurrence
with breast conserving surgery and radiotherapy rather thanmastectomy after systemic therapy. Patients with locally advanced or inflammatory breast cancer Patient group
● Offer local treatment by mastectomy (or, in exceptional cases,
breast conserving surgery) followed by radiotherapy.
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Adjuvant therapy planning All patients with early invasive breast cancer ● After surgery, consider adjuvant therapy at the MDT meeting. Record all decisions.
● Make decisions about adjuvant therapy based on assessment of prognostic and predictive factors
and potential benefits and side effects of the treatment. Make decisions following discussion ofthese factors with the patient.
● Consider using Adjuvant! Online (www.adjuvantonline.com) to support estimations of individual
prognosis and absolute benefit of adjuvant treatment.
All patients with early breast cancer ● Start adjuvant chemotherapy or radiotherapy as soon as clinically possible and within 31 days Assessment and treatment of bone loss in patients starting adjuvant treatment
● Offer baseline DEXA to patients with early invasive breast cancer who:
– are starting adjuvant AI treatment– have treatment-induced menopause– are starting ovarian ablation/suppression therapy.
● Do not offer DEXA to patients with early invasive breast cancer who are receiving tamoxifen alone,
regardless of pretreatment menopausal status.
● 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 froma UK expert group’7.
6 Department of Health (2007). Cancer reform strategy. London: Department of Health. (At present no equivalent target hasbeen set by the Welsh Assembly Government.)7 Reproduced in appendix 2 of the full guideline. See www.nice.org.uk/CG80
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Adjuvant therapy Endocrine therapy Patient group
ER-positive early invasive breast cancer,
● Do not offer ovarian ablation/suppression to women having
● Offer ovarian ablation/suppression in addition to tamoxifen to
women who have been offered chemotherapy but chosen notto have it.
ER-positive early invasive breast cancer,
● Offer AI, either anastrozole or letrozole, as initial adjuvant
therapy. Offer tamoxifen if AI is not tolerated or
ER-positive early invasive breast cancer,
● Offer AI, either exemestane or anastrozole, instead
at low risk8 and who have been treated with tamoxifen for 2–3 years
● Offer additional treatment with the AI letrozole for 2–3 years.
invasive breast cancer, postmenopausal women who have been treated with tamoxifen for 5 years
ER-positive early invasive breast cancer,
● The AIs anastrozole, exemestane and letrozole, within their
licensed indications, are recommended as options foradjuvant treatment9.
● Discuss with women the risks and benefits of each treatment
option. Consider previous treatment with tamoxifen, licensedindications and side-effect profiles of individual drugs and, inparticular, assessed risk of recurrence9.
8 Low-risk patients are those in the EPG or GPG (excellent or good prognostic group) in the Nottingham Prognostic Index(NPI), who have 10-year predictive survivals of 96% and 93%, respectively. They would have similar predictions usingAdjuvant! Online. 9 This recommendation is from ‘Breast cancer (early) – hormonal treatments’ (NICE technology appraisal guidance 112). Chemotherapy Patient group
● Offer docetaxel as part of adjuvant chemotherapy regimen. ● Do not offer paclitaxel. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Biological therapy Patient group
● Offer trastuzumab, given at 3-week intervals for 1 year or
until disease recurrence (whichever is shortest).
● Assess cardiac function before starting treatment with
trastuzumab. Do not offer if any of the following are present:– LVEF ≤ 55%– history of documented congestive heart failure– high-risk uncontrolled arrhythmias– angina pectoris requiring medication– clinically significant valvular disease– evidence of transmural infarction on ECG– poorly controlled hypertension.
● Repeat cardiac functional assessments every 3 months during
● If LVEF drops by ≥ 10 percentage (ejection) points from
baseline and to < 50%, stop trastuzumab. Restart trastuzumabonly after further cardiac assessment and fully informeddiscussion with the patient about the risks and benefits. Radiotherapy (breast) for patients with early invasive breast cancer Patient group
● Patients should have breast radiotherapy.
● Use external beam radiotherapy, giving 40Gy in 15 fractions
● Offer external beam boost to the site of local excision.
● Inform patients that cosmesis is likely to be worse, particularly
● Consider entering patients into SUPREMO trial assessing value
of postoperative radiotherapy (www.supremo-trial.com).
10 Includes patients with ≥ 4 positive axillary lymph nodes or involved resection margins.
11 Includes patients with 1–3 involved lymph nodes, lymphovascular invasion, histological grade 3 tumours, ER-negativetumours, and those aged < 40 years. 12 For example, most patients who are lymph node-negative. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Radiotherapy (breast) for patients with DCIS Patient group
● Offer breast radiotherapy. Discuss with patients the potential
Radiotherapy (nodal) for patients with early breast cancer Patient group
● Do not offer radiotherapy to the axilla or SCF.
● Do not offer radiotherapy to the axilla.
Positive axillary SLNB or 4-node sample;
● Offer radiotherapy to the axilla. (See Assessment of the axilla,
Lymph node-positive, ≥ 4 involved nodes
Lymph node-positive, 1–3 involved nodes
and other poor prognostic factors (for example, T3 and/or histological grade 3 tumours), and good performance status
● Do not offer radiotherapy to the internal mammary chain. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Complications of local treatment and menopausal symptoms Complication Information and advice
information before offering surgery and radiotherapy.
● Identify pre-existing shoulder conditions
● Refer patients to the physiotherapy department
if they report a persistent reduction in arm and
shoulder mobility after breast cancer treatment.
● Breast units should have written local guidelines
agreed with the physiotherapy department forpostoperative physiotherapy regimens.
● Discontinue HRT in women diagnosed with early
● Do not offer HRT (including oestrogen/
progestogen combination) routinely to women
with menopausal symptoms and a history of breast cancer.
● HRT13 may, in exceptional cases, be given to
women with early breast cancer who have severe menopausal symptoms, as long as the woman has been fully informed about the associated risks.
● SSRI antidepressants (paroxetine14 and
fluoxetine14) may be used to relieve menopausal symptoms, particularly hot flushes, but not in women taking tamoxifen.
● Clonidine, venlafaxine14 and gabapentin14 should
only be used to treat hot flushes after the woman has been fully informed of the significant side effects.
● Tibolone, progestogens, soy (isoflavone), red
clover, black cohosh, vitamin E and magnetic devices are not recommended to treat menopausal symptoms.
13 The summaries of product characteristics state that HRT is contraindicated in women with known, past or suspectedbreast cancer. Informed consent should be obtained and documented.
14 These drugs are not licensed for the stated use. Informed consent should be obtained and documented. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Follow-up care Follow-up imaging ● Offer annual mammography to all patients with early breast cancer, including DCIS, until they
● Patients diagnosed with early breast cancer who are already eligible for screening should have
● Do not offer mammography of the ipsilateral soft tissues after mastectomy.
● Do not offer ultrasound or MRI for routine post-treatment surveillance in patients who have had
Clinical follow-up ● After adjuvant treatment (including chemotherapy and/or radiotherapy, where indicated) is
completed, discuss with patients where they would like follow-up to be undertaken. They maychoose primary, secondary or shared care.
● Patients should follow an agreed, written care plan, recorded by a named healthcare professional (or
professionals). A copy should be sent to the GP and a copy given to the patient. It should include:− designated named healthcare professionals− dates for review of any adjuvant therapy− details of surveillance mammography − contact details for immediate referral to specialist care, and− contact details for support services, for example, support for patients with lymphoedema.
15 For patients who have entered the NHSBSP/BTWSP, or who have had 5 years of annual mammography follow-up, werecommend the NHSBSP/BTWSP stratify screening frequency in line with risk category. NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Further information Ordering information
Alendronate, etidronate, risedronate, raloxifene
You can download the following documents from
and strontium ranelate for the primary prevention
of osteoporotic fragility fractures inpostmenopausal women. NICE technology
● The NICE guideline – all the recommendations.
appraisal guidance 160 (2008). Available from
● A quick reference guide (this document) –
Brachytherapy as the sole method of adjuvant
radiotherapy for breast cancer after local excision.
● ‘Understanding NICE guidance’ – information
NICE interventional procedure guidance 268
(2008). Available from www.nice.org.uk/IPG268
● The full guideline – all the recommendations,
Hormonal therapies for the adjuvant treatment of
early oestrogen-receptor-positive breast cancer.
reviews of the evidence they were based on.
NICE technology appraisal guidance 112 (2006). Available from www.nice.org.uk/TA112
For printed copies of the quick reference guide or‘Understanding NICE guidance’, phone NICE
Familial breast cancer: the classification and care
of women at risk of familial breast cancer in
primary, secondary and tertiary care (partial
update of NICE clinical guideline 14). NICE
clinical guideline 41 (2006). Available from
● N1793 (‘Understanding NICE guidance’). Related NICE guidance
Endoscopic axillary lymph node retrieval for breast cancer. NICE interventional procedure
For information about NICE guidance that
Referral guidelines for suspected cancer. NICE
clinical guideline 27 (2005). Available from
Advanced breast cancer: diagnosis and treatment.
NICE clinical guideline 81 (2009). Available fromwww.nice.org.uk/CG81
Interstitial laser therapy for breast cancer. NICEinterventional procedure guidance 89 (2004).
Alendronate, etidronate, risedronate, raloxifene,
strontium ranelate and teriparatide for thesecondary prevention of osteoporotic fragility
Improving supportive and palliative care for adults
with cancer. Cancer service guidance (2004).
technology appraisal guidance 161 (2008).
Improving outcomes in breast cancer – manualupdate. Cancer service guidance (2002). Availablefrom www.nice.org.uk/csgbc
NICE clinical guideline 80 Quick reference guide Early and locally advanced breast cancer Updating the guideline
Osteoporosis: assessment of fracture risk and the
This guideline will be updated as needed, and
prevention of osteoporotic fractures in individuals
information about the progress of any update
at high risk. NICE clinical guideline (publication
NICE has developed tools to help organisations
implement this guidance (listed below). These are
– costing report to estimate the national
available on our website (www.nice.org.uk/CG80).
savings and costs associated with implementation
● Slides highlighting key messages for
– costing template to estimate the local costs
● Audit support for monitoring local practice. NICE clinical guideline 80 Quick reference guide National Institute for Health and Clinical Excellence
Declaración de los Derechos del Hombre y del Ciudadano de 1789 Los Representantes del Pueblo Francés, constituidos en Asamblea Nacional, considerando que la ignorancia, el olvido o el menosprecio de los derechos del Hombre son las únicas causas de las calamidades públicas y de la corrupción de los Gobiernos, han resuelto exponer, en una Declaración solemne, los derechos naturales, in
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