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Early and locally advanced breast cancer

About

What is covered

This pathway covers the diagnosis and treatment of early and locally advanced breast cancer.
Breast cancer is the most common cancer in women. Most women with breast cancer do not have a family history of the disease, but it can be hereditary. In men breast cancer is rare.
Early breast cancer is subdivided into two major categories: in situ disease, mainly in the form of DCIS, and invasive cancer. Both are heterogeneous processes with very variable appearances, biology and clinical behaviour. A small proportion of people 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 considerable number of women who have been previously treated with curative intent subsequently develop either a local recurrence or metastases.

Updates

Updates to this pathway

27 September 2016 Pathway restructured, and summarised recommendations replaced with full recommendations.
15 June 2016 Breast cancer (NICE quality standard 12) updated in this pathway.
11 November 2015 Link to the menopause pathway added to adjuvant therapy planning.
30 June 2014 Link to the advanced breast cancer pathway added.
24 September 2013 'Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat' (NICE diagnostic guidance 10) added.
6 August 2013 'Intraoperative tests (RD-100i OSNA system and Metasin test) for detecting sentinel lymph node metastases in breast cancer' (NICE diagnostic guidance 8) recommendations added. Minor maintenance updates.
25 October 2011 Separate pathways created for familial breast cancer, early and locally advanced breast cancer, and advanced breast cancer.
30 September 2011 Breast cancer (NICE quality standard 12) added to this pathway.
1 August 2011 Arrow on Advanced breast cancer: Endocrine therapy path corrected.

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Short Text

Everything NICE has said on early and locally advanced breast cancer in an interactive flowchart.

What is covered

This pathway covers the diagnosis and treatment of early and locally advanced breast cancer.
Breast cancer is the most common cancer in women. Most women with breast cancer do not have a family history of the disease, but it can be hereditary. In men breast cancer is rare.
Early breast cancer is subdivided into two major categories: in situ disease, mainly in the form of DCIS, and invasive cancer. Both are heterogeneous processes with very variable appearances, biology and clinical behaviour. A small proportion of people 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 considerable number of women who have been previously treated with curative intent subsequently develop either a local recurrence or metastases.

Updates

Updates to this pathway

27 September 2016 Pathway restructured, and summarised recommendations replaced with full recommendations.
15 June 2016 Breast cancer (NICE quality standard 12) updated in this pathway.
11 November 2015 Link to the menopause pathway added to adjuvant therapy planning.
30 June 2014 Link to the advanced breast cancer pathway added.
24 September 2013 'Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat' (NICE diagnostic guidance 10) added.
6 August 2013 'Intraoperative tests (RD-100i OSNA system and Metasin test) for detecting sentinel lymph node metastases in breast cancer' (NICE diagnostic guidance 8) recommendations added. Minor maintenance updates.
25 October 2011 Separate pathways created for familial breast cancer, early and locally advanced breast cancer, and advanced breast cancer.
30 September 2011 Breast cancer (NICE quality standard 12) added to this pathway.
1 August 2011 Arrow on Advanced breast cancer: Endocrine therapy path corrected.

Sources

NICE guidance and other sources used to create this pathway.
Improving outcomes in breast cancer (2002) NICE cancer service guidance 1
Breast reconstruction using lipomodelling after breast cancer treatment (2012) NICE interventional procedure guidance 417
Image-guided radiofrequency excision biopsy of breast lesions (2009) NICE interventional procedure guidance 308
Endoscopic mastectomy and endoscopic wide local excision for breast cancer (2009) NICE interventional procedure guidance 296
Laparoscopic mobilisation of the greater omentum for breast reconstruction (2008) NICE interventional procedure guidance 253
Liposuction for chronic lymphoedema (2008) NICE interventional procedure guidance 251
Endoscopic axillary lymph node retrieval for breast cancer (2005) NICE interventional procedure guidance 147
Interstitial laser therapy for breast cancer (2004) NICE interventional procedure guidance 89
Breast cancer (2011 updated 2016) NICE quality standard 12

Quality standards

Breast cancer

These quality statements are taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statements

Timely diagnosis

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with suspected breast cancer referred to specialist services are offered the triple diagnostic assessment in a single hospital visit.

Rationale

Early diagnosis of breast cancer allows for prompt treatment, which results in better health outcomes for people with breast cancer. Giving people with suspected breast cancer the triple diagnostic assessment at a single hospital visit will help to ensure rapid diagnosis. It will also help to reduce the anxiety and stress associated with multiple visits for different parts of the triple diagnostic assessment.

Quality measures

Structure
Evidence of local arrangements to ensure that specialist services carry out the triple diagnostic assessment at a single hospital visit in people referred with suspected breast cancer.
Data source: Local data collection.
Process
Proportion of people with suspected breast cancer referred to specialist services who receive the triple diagnostic assessment in a single visit.
Numerator – the number in the denominator who receive the triple diagnostic assessment in a single visit.
Denominator – the number of people with suspected breast cancer referred to specialist services.
Data source: Local cancer data.
Outcome
a) Stage at diagnosis of breast cancer.
Data source: Local data collection.
b) Breast cancer survival rates.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and specialist breast cancer services) ensure that systems are in place to provide triple diagnostic assessment in a single hospital visit for people referred to specialist services with suspected breast cancer.
Healthcare professionals (such as doctors, nurses and specialists) ensure that people with suspected breast cancer referred to specialist services have the triple diagnostic assessment in a single hospital visit.
Commissioners (such as clinical commissioning groups) ensure that they commission specialist services that provide triple diagnostic assessment in a single hospital visit for people with suspected breast cancer.

What the quality statement means for patients, people using services and carers

People who have been referred to a breast cancer specialist are offered a full assessment carried out at a single visit to the hospital or specialist unit. The assessment involves an examination, breast imaging and a biopsy (if needed). During the biopsy a small amount of breast tissue is removed and tested for cancer. Having the assessment in a single visit helps to ensure that people receive a quick diagnosis and do not need to make several hospital visits.

Source guidance

Definitions of terms used in this quality statement

Triple diagnostic assessment
This consists of clinical assessment, mammography and/or ultrasound imaging, and fine needle aspiration or core biopsy.
[Improving outcomes in breast cancer (NICE guideline CSG1)]

Preoperative MRI scan

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with biopsy-proven invasive breast cancer or ductal carcinoma in situ (DCIS) are not offered a preoperative MRI scan unless there are specific clinical indications for its use.

Rationale

An MRI scan is not needed to assess a tumour before surgery for people with biopsy-proven invasive breast cancer or DCIS except in specific clinical situations. Carrying out an unnecessary preoperative MRI scan may cause additional stress without any benefit and waste healthcare resources.

Quality measures

Structure
Evidence of local arrangements to ensure that people with biopsy-proven invasive breast cancer or DCIS do not have an MRI scan for preoperative assessment unless there are specific clinical indications for its use.
Data source: Local data collection.
Process
Proportion of MRI scans for preoperative assessment of people with biopsy-proven invasive breast cancer or DCIS in which there is a specific clinical indication for its use.
Numerator – the number in the denominator in which there is a specific clinical indication for preoperative MRI.
Denominator – the number of MRI scans for preoperative assessment of people with biopsy-proven invasive breast cancer or DCIS.
Data source: Local data collection.
Outcome
Patient satisfaction with preoperative treatment of people with biopsy-proven invasive breast cancer or DCIS.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and specialist breast cancer services) ensure that systems are in place so that people with biopsy-proven invasive breast cancer or DCIS are not offered a preoperative MRI scan unless there are specific clinical indications for its use.
Healthcare professionals (such as doctors, nurses and specialists) are aware of local referral pathways for breast cancer to ensure that people with biopsy-proven invasive breast cancer or DCIS are not offered a preoperative MRI scan unless there are specific clinical indications for its use.
Commissioners (such as clinical commissioning groups) ensure that they commission services in which people with biopsy-proven invasive breast cancer or DCIS are not offered a preoperative MRI scan unless there are specific clinical indications for its use.

What the quality statement means for patients, people using services and carers

People with invasive breast cancer that has been confirmed by a biopsy of their tumour, and people with a type of cancer called ductal carcinoma in situ (or DCIS), are not usually offered an MRI scan before surgery.

Source guidance

Definitions of terms used in this quality statement

Specific clinical indication for preoperative MRI scan
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.
[Early and locally advanced breast cancer: diagnosis and treatment (NICE guideline CG80) recommendation 1.1.1]

Gene expression profiling

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with oestrogen receptor-positive (ER-positive), human epidermal growth factor receptor 2-negative (HER2-negative) and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence are offered gene expression profiling with Oncotype DX.

Rationale

Gene expression profiling aims to identify certain genes found in breast cancer tumours. Testing for the levels of expression of these genes can give an indication of how a tumour might develop, which can help in planning treatment. Oncotype DX has been shown to be effective in predicting the course of disease in people with ER-positive, HER2-negative and lymph node-negative early breast cancer who have been assessed as being at intermediate risk of distant recurrence. This information can help with decisions about prescribing chemotherapy after surgery.

Quality measures

Structure
Evidence of local arrangements to provide gene expression profiling with Oncotype DX for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.
Data source: Local data collection.
Process
Proportion of people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence who receive gene expression profiling with Oncotype DX.
Numerator – the number in the denominator who receive gene expression profiling with Oncotype DX.
Denominator – the number of people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.
Data source: Local data collection.
Outcome
a) Breast cancer recurrence (distant and local).
Data source: Local data collection.
b) Incidence of adverse events from chemotherapy.
Data source: Local data collection.
c) Mortality from breast cancer.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and specialist breast cancer services) ensure that systems are in place for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence to have gene expression profiling with Oncotype DX.
Healthcare professionals (such as doctors, nurses and specialists) ensure that people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence have gene expression profiling with Oncotype DX.
Commissioners (such as clinical commissioning groups) ensure that they commission services that undertake gene expression profiling with Oncotype DX for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.

What the quality statement means for patients, people using services and carers

People diagnosed with a particular type of early breast cancer (called oestrogen receptor-positive, human epidermal growth factor receptor 2-negative and lymph node-negative early breast cancer), who have been assessed as being at particular risk of the cancer spreading, are offered a test that can help to predict how the cancer might develop. This information can be used to help with decisions about chemotherapy after surgery to remove the cancer.

Source guidance

Definitions of terms used in this quality statement

Gene expression profiling with Oncotype DX
At the time of publication (June 2016), Oncotype DX was the only test (of four available to the NHS) recommended by NICE as an option for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are assessed as being at intermediate risk of distant recurrence.
Intermediate risk
Intermediate risk of distant recurrence is defined as a Nottingham Prognostic Index (NPI) score above 3.4. It is anticipated that an NPI score can be simply calculated from information that is routinely collected about people with breast cancer. The NICE diagnostics guidance also highlights other decision-making tools or protocols are also currently used in the NHS and these may also be used to identify people at intermediate risk.

ER and HER2 receptor status

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate) have the oestrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) status of the tumour assessed.

Rationale

Information on the ER and HER2 status of breast cancer tumours is used to classify the primary tumour and decide how best to treat and manage the cancer. If breast cancer recurs, the ER and HER2 status of the tumour may be different from that of the original primary tumour. Therefore recurrent tumours (either at the site of the primary tumour or metastatic tumours) should be assessed for their ER and HER2 status, if clinically appropriate.

Quality measures

Structure
a) Evidence of local arrangements and written clinical protocols to ensure that people with newly diagnosed invasive breast cancer have the ER and HER2 status of the tumour assessed.
Data source: Local data collection.
b) Evidence of local arrangements and written clinical protocols to ensure that people with recurrent breast cancer have the ER and HER2 status of the tumour assessed, if clinically appropriate.
Data source: Local data collection.
Process
a) Proportion of people with newly diagnosed invasive breast cancer who have the ER status of the tumour assessed.
Numerator – the number of people in the denominator who have the ER status of the tumour assessed.
Denominator – the number of people with newly diagnosed invasive breast cancer.
Data source: Local data collection.
b) Proportion of people with newly diagnosed invasive breast cancer who have the HER2 status of the tumour assessed.
Numerator – the number of people in the denominator who have the HER2 status of the tumour assessed.
Denominator – the number of people with newly diagnosed invasive breast cancer.
Data source: Local data collection.
c) Proportion of people with histologically confirmed recurrent breast cancer who have the ER status of the tumour assessed, if clinically appropriate.
Numerator – the number of people in the denominator who have the ER status of the tumour assessed, if clinically appropriate.
Denominator – the number of people with histologically confirmed recurrent breast cancer.
Data source: Local data collection.
d) Proportion of people with histologically confirmed recurrent breast cancer who have the HER2 status of the tumour assessed, if clinically appropriate.
Numerator – the number of people in the denominator who have the HER2 status of the tumour assessed, if clinically appropriate.
Denominator – the number of people with histologically confirmed recurrent breast cancer.
Data source: Local data collection.
Outcome
Breast cancer survival rates.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and tertiary care specialist centres) ensure that systems are in place for the ER and HER2 status of the tumour to be assessed in people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).
Healthcare professionals (such as doctors, nurses and specialists) ensure the ER and HER2 status of the tumour are assessed in people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).
Commissioners (such as clinical commissioning groups) ensure they commission services that assess the ER and HER2 status of the tumour for people with newly diagnosed invasive breast cancer and those with recurrent breast cancer (if clinically appropriate).

What the quality statement means for patients, people using services and carers

People with newly diagnosed invasive breast cancer or with breast cancer that has come back or spread have tissue from their tumour tested to find out more about the type of cancer (whether it is a type called oestrogen receptor-positive or human epidermal growth receptor 2-positive). This helps to make sure that the person has the treatment and care that will work best for them.

Source guidance

  • Advanced breast cancer: diagnosis and treatment (2009) NICE guideline CG81, recommendation 1.1.8. (In 2015, NICE decided that the recommendations in this guideline on the assessment of ER and HER2 should be updated. The update is expected to publish in June 2017. If the recommendations change, this quality statement will be reviewed.)
  • Early and locally advanced breast cancer: diagnosis and treatment (2009) NICE guideline CG80, recommendations 1.6.1 and 1.6.3

Multidisciplinary team management of metastatic breast cancer

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with breast cancer who develop metastatic disease have their treatment and care managed by a multidisciplinary team.

Rationale

When a multidisciplinary team manages the treatment and care of people with advanced breast cancer who develop metastatic disease, health outcomes are improved. In particular, the role of the multidisciplinary team involves assessing the patient, discussing potential treatments for the cancer and symptom relief, and reviewing the impact of treatment across the whole care pathway.

Quality measures

Structure
Evidence of local arrangements to ensure that a multidisciplinary team manages the treatment and care of people with breast cancer who develop metastatic disease.
Data source: Local data collection.
Process
Proportion of people with breast cancer who develop metastatic disease who have their treatment and care managed by a multidisciplinary team.
Numerator – the number in the denominator who have their treatment and care managed by a multidisciplinary team.
Denominator – the number of people with breast cancer who develop metastatic disease.
Data source: Local data collection.
Outcome
a) Breast cancer recurrence (distant and local).
Data source: Local data collection.
b) Incidence of adverse events from chemotherapy.
Data source: Local data collection.
c) Mortality from breast cancer.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and tertiary care specialist services) ensure that systems are in place for people with breast cancer who develop metastatic disease to have their treatment and care managed by a multidisciplinary team.
Healthcare professionals (such as doctors, nurses and specialists) are aware of care pathways in place to ensure that people with breast cancer who develop metastatic disease have their treatment and care managed by a multidisciplinary team.
Commissioners (such as clinical commissioning groups) ensure that they commission services that have a multidisciplinary team who manage the treatment and care of people with breast cancer who develop metastatic disease.

What the quality statement means for patients, people using services and carers

People with breast cancer that has spread to other parts of the body (known as metastatic disease) have their treatment and care managed by a team of healthcare professionals who specialise in different areas of care. The team carry out an assessment and discuss all possible treatment options to help make sure the person has the treatment and care that will work best for them.

Source guidance

Key worker

This quality statement is taken from the breast cancer quality standard. The quality standard defines clinical best practice in breast cancer care and should be read in full.

Quality statement

People with locally advanced, metastatic or distant recurrent breast cancer are assigned a key worker.

Rationale

Assigning key workers to people with locally advanced, metastatic or distant recurrent breast cancer leads to better health outcomes. Key workers provide information and support for the person with breast cancer throughout their care. This can help to improve patient experience because people know they have someone who they can discuss their care with. It also helps to ensure that any care takes the person’s needs into account.

Quality measures

Structure
Evidence of local arrangements to ensure that people with locally advanced, metastatic or distant recurrent breast cancer are assigned a key worker.
Data source: Local data collection.
Process
a) Proportion of people with locally advanced breast cancer with an assigned key worker.
Numerator – the number in the denominator with an assigned key worker.
Denominator – the number of people with locally advanced breast cancer.
Data source: Local data collection.
b) Proportion of people with metastatic breast cancer with an assigned key worker.
Numerator – the number in the denominator with an assigned key worker.
Denominator – the number of people with metastatic breast cancer.
Data source: Local data collection.
c) Proportion of people with distant recurrent breast cancer with an assigned key worker.
Numerator – the number in the denominator with an assigned key worker.
Denominator – the number of people with distant recurrent breast cancer.
Data source: Local data collection.
Outcome
Patient satisfaction with information and support received throughout their care for breast cancer.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and tertiary care specialist centres) ensure that systems are in place for people with locally advanced, metastatic or distant recurrent breast cancer to have a key worker.
Healthcare professionals (such as GPs, practice nurses and specialist therapeutic radiographers) ensure they are aware of referral pathways in place so people with locally advanced, metastatic or distant recurrent breast cancer have a key worker.
Commissioners (such as clinical commissioning groups) ensure that they commission services that assign key workers to people with locally advanced, metastatic or distant recurrent breast cancer.

What the quality statement means for patients, people using services and carers

People with locally advanced, metastatic or distant recurrent breast cancer have a healthcare professional (often a nurse who specialises in breast cancer) assigned to them as their ‘key worker’. The key worker gives information and support throughout the person’s care.

Source guidance

Definitions of terms used in this quality statement

Key worker
This refers to a named healthcare professional (such as a clinical nurse specialist) who can give information and support throughout the patient pathway to the person with breast cancer and/or their carers.
[Advanced breast cancer: diagnosis and treatment (NICE guideline CG81) and expert consensus]

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Supporting information

Glossary

Axillary lymph node dissection (also known as axillary clearance)
Ductal carcinoma in situ
Dual energy X-ray absorptiometry
Electrocardiograph
Oestrogen receptor
Human epidermal growth factor 2
Left ventricular ejection fraction
Magnetic resonance imaging
Sentinel lymph node biopsy

Paths in this pathway

Pathway created: May 2011 Last updated: September 2016

© NICE 2016

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