Early and locally advanced breast cancer Early 

and locally advanced breast cancer 

overviewerview 
NICE Pathways bring together all NICE guidance, quality standards and other 
NICE information on a specific topic. 
NICE Pathways are interactive and designed to be used online. They are updated 
regularly as new NICE guidance is published. To view the latest version of this 
pathway see: 
http://pathways.nice.org.uk/pathways/early-and-locally-advanced-breast-cancer 
Pathway last updated: 03 January 2017 
This document contains a single pathway diagram and uses numbering to link the 
boxes to the associated recommendations. 
Copyright © NICE 2017. All rights reserved 
 
Early and locally advanced breast cancer path Early and locally advanced breast cancer 
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1 Person with suspected breast cancer 
No additional information 
2 Diagnosis and referral 
Patients with symptoms that could be caused by breast cancer are referred by their GP to 
designated breast clinics in local hospitals (see breast cancer in the NICE pathway on suspected 
cancer recognition and referral). 
In addition, women aged between 50 and 70 are invited for screening mammography every 3 
years through the NHSBSP in England or the 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 rapid and accurate 
diagnosis in the NICE cancer service guideline on improving outcomes in breast cancer). 
Discontinuing hormone replacement therapy at diagnosis 
Discontinue HRT in women who are diagnosed with breast cancer. 
Quality standards 
The following quality statement is relevant to this part of the interactive flowchart. 
1. Timely diagnosis 
3 Information and support 
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. 
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All patients with breast cancer should be offered prompt access to specialist psychological 
support, and, where appropriate, psychiatric services. 
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. 
Offer information and counselling for all women about the possibility of early menopause and 
menopausal symptoms associated with breast cancer treatment. 
NICE has written information for the public explaining its guidance on early and locally 
advanced breast cancer 
Quality standards 
The following quality statement is relevant to this part of the interactive flowchart. 
6. Key worker 
4 Assessment and staging 
MRI 
The routine use of MRI of the breast is not recommended in the preoperative assessment of 
patients with biopsy-proven invasive breast cancer or DCIS. 
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. 
See also the NICE pathway on preoperative tests. 
Ultrasound and needle sampling 
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. 
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NICE has published a medtech innovation briefing on Aixplorer ShearWave Elastography for 
ultrasound imaging and assessing suspicious breast lesions. 
Biopsy 
NICE has published interventional procedures guidance on image-guided radiofrequency 
excision biopsy of breast lesions with special arrangements for clinical governance, consent and 
audit or research. 
NICE has published a medtech innovation briefing on ATEC system for vacuum-assisted breast 
biopsy. 
Quality standards 
The following quality statement is relevant to this part of the interactive flowchart. 
2. Preoperative MRI scan 
5 Primary systemic and neoadjuvant therapy 
Early breast cancer 
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. 
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 
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. 
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Neoadjuvant therapy 
The following recommendation is from NICE technology appraisal guidance on pertuzumab for 
the neoadjuvant treatment of HER2-positive breast cancer. 
Pertuzumab, in combination with trastuzumab and chemotherapy, is recommended as an option 
within its marketing authorisation for the neoadjuvant treatment of human epidermal growth 
factor receptor 2 (HER2) positive breast cancer; that is, in adults with locally advanced, 
inflammatory or early-stage breast cancer at high risk of recurrence. It is recommended only if 
the company provides pertuzumab with the discount agreed in the patient access scheme. 
NICE has written information for the public explaining its guidance on pertuzumab. 
6 Surgery to the breast 
Ductal carcinoma in situ 
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. 
Enter patients with screen-detected DCIS into the Sloane Project (UK DCIS audit). 
All breast units should audit their recurrence rates after treatment for DCIS. 
Paget's disease 
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. 
Intraoperative tests 
The following recommendations are from NICE diagnostics guidance on intraoperative tests 
(RD-100i OSNA system and Metasin test) for detecting sentinel lymph node metastases in breast 
cancer. 
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Whole lymph node analysis using the RD-100i OSNA system is recommended as an option for 
detecting sentinel lymph node metastases during breast surgery in people with early invasive 
breast cancer who have a SLNB and in whom ALND will be considered. Details of the 
development of a national registry are included in section 7 of DG8. 
The Metasin test is not recommended for detecting sentinel lymph node metastases in people 
with early invasive breast cancer in routine clinical NHS practice. The Metasin test shows 
promise and the development of robust evidence is recommended to demonstrate its utility in 
clinical practice. 
Introperative radiotherapy 
NICE has published a medtech innovation briefing on axxent electronic brachytherapy system 
for early stage breast cancer. 
Interventional procedures 
NICE has published guidance that the following procedures should be used only in the context of 
research: 
endoscopic mastectomy and endoscopic wide local excision for breast cancer 
interstitial laser therapy for breast cancer. 
7 Surgery to the axilla 
Invasive breast cancer 
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. SLNB is the preferred technique. 
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. 
Perform SLNB using the dual technique with isotope and blue dye. 
Breast units should audit their axillary recurrence rates. 
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Ductal carcinoma in situ 
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. Patients considered at high risk of invasive disease include those with a palpable mass or 
extensive microcalcifications. 
Offer SLNB to all patients who are having a mastectomy for DCIS. 
Evaluation and management of a positive sentinel lymph node 
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 ALND because it gives additional staging information. 
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. 
Endoscopic axillary lymph node retrieval 
NICE has published interventional procedures guidance on endoscopic axillary lymph node 
retrieval for breast cancer with special arrangements for consent and for audit or research. 
Functional exercises to be started the day after surgery 
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. 
8 When to offer 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 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. 
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Interventional procedures 
NICE has published guidance on the use of the following procedures with normal arrangements 
for consent and for audit or research: 
breast reconstruction using lipomodelling after breast cancer treatment 
laparoscopic mobilisation of the greater omentum for breast reconstruction. 
9 Post-operative assessment 
Assess ER status of all invasive breast cancers, using immunohistochemistry with a standardised 
and qualitatively assured methodology, and report the results quantitatively. 
Do not routinely assess progesterone receptor status of tumours in patients with invasive breast 
cancer. 
Test HER2 status of all invasive breast cancers, using a standardised and qualitatively assured 
methodology. 
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. 
Quality standards 
The following quality statement is relevant to this part of the interactive flowchart. 
4. ER and HER2 receptor status 
10 Adjuvant therapy 
See Early and locally advanced breast cancer / Adjuvant therapy for early and locally advanced 
breast cancer 
11 Complications 
See Early and locally advanced breast cancer / Complications of early or locally advanced breast 
cancer 
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12 Follow-up 
Follow-up imaging 
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. 
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. 
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 been 
treated for early invasive breast cancer or DCIS. 
Clinical follow-up 
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. 
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. 
For patients whose condition progresses to advanced breast cancer, see the NICE pathway on 
advanced breast cancer. 
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13 Service organisation and training 
Service organisation 
NICE has published cancer service guidance on: 
improving outcomes in breast cancer and 
improving supportive and palliative care for adults with cancer. 
Training 
All members of the breast cancer clinical team should have completed an accredited 
communication skills training programme. 

14 NICE pathway on advanced breast cancer 

See Advanced breast cancer 
15 NICE pathway on patient experience 
See Patient experience in adult NHS services 
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Glossary 
ALND 
axillary lymph node dissection (also known as axillary clearance) 
BTWSP 
Breast Test Wales Screening Programme 
DCIS 
ductal carcinoma in situ 
DEXA 
dual energy X-ray absorptiometry 
ECG 
electrocardiograph 
ER 
oestrogen receptor 
HER2 
human epidermal growth factor 2 
HRT 
hormone replacement therapy 
MRI 
magnetic resonance imaging 
NHSBSP 
NHS Breast Screening Programme 
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SLNB 
sentinel lymph node biopsy 
Sources 
Early and locally advanced breast cancer: diagnosis and treatment (2009) NICE guideline CG80 
Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer (2016) NICE 
technology appraisal guidance 424 
Intraoperative tests (RD-100i OSNA system and Metasin test) for detecting sentinel lymph node 
metastases in breast cancer (2013) NICE diagnostics guidance 8 
Your responsibility 
The guidance in this pathway represents the view of NICE, which was arrived at after careful 
consideration of the evidence available. Those working in the NHS, local authorities, the wider 
public, voluntary and community sectors and the private sector should take it into account when 
carrying out their professional, managerial or voluntary duties. 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 to promoting equality of 
opportunity. Nothing in this guidance should be interpreted in a way which would be 
inconsistent with compliance with those duties. 
Copyright 
Copyright © National Institute for Health and Care Excellence 2017. All rights reserved. NICE 
copyright material can be downloaded for private research and study, and may be reproduced for 
educational and not-for-profit purposes. No reproduction by or for commercial organisations, or 
for commercial purposes, is allowed without the written permission of NICE. 
Contact NICE 
National Institute for Health and Care Excellence Level 1A, City Tower Piccadilly Plaza 
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www.nice.org.uk 
nice@nice.org.uk 
0845 003 7781 
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