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Early and locally advanced breast cancer overview

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These are the paths in the Early and locally advanced breast cancer pathway:

Early and locally advanced breast cancer HAI

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

Patient-centred care

Patients and healthcare professionals have rights and responsibilities as set out in the NHS Constitution for England – all NICE guidance is written to reflect these. Treatment and care should take into account individual needs and preferences. People should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If the person is under 16, their family or carers should also be given information and support to help the child or young person to make decisions about their treatment. Healthcare professionals should follow the Department of Health's advice on consent. If someone does not have capacity to make decisions, healthcare professionals should follow the code of practice that accompanies the Mental Capacity Act and the supplementary code of practice on deprivation of liberty safeguards.
For young people moving between paediatric and adult services, care should be planned and managed according to the best practice guidance described in the Department of Health’s Transition: getting it right for young people.
Adult and paediatric healthcare teams should work jointly to provide assessment and services to young people. Diagnosis and management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

Updates to this pathway

30 June 2014 Link to the advanced breast cancer pathway added to complications of local treatments and menopausal symptoms.
10 June 2014 Minor maintenance updates
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 to adjuvant therapy planning. Minor maintenance updates.
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.
12 October 2012 Minor maintenance updates.
11 July 2012 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 quality standard added.
1 August 2011 Arrow on Advanced breast cancer: Endocrine therapy path corrected.

Short Text

The diagnosis and treatment of early and locally advanced breast cancer

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.

Quality standards

Breast cancer quality standard

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

Referral

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 presenting with symptoms that suggest breast cancer are referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people presenting with symptoms that suggest breast cancer are referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
Process
Proportion of people presenting with symptoms that suggest breast cancer who are referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
Numerator – the number of people in the denominator referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
Denominator – the number of people presenting with symptoms that suggest breast cancer.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people presenting with symptoms that suggest breast cancer to be referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
Healthcare professionals ensure they are aware of local referral pathways for breast cancer to ensure that people with symptoms that suggest breast cancer are referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
Commissioners ensure they commission services that make sure people presenting with symptoms that suggest breast cancer are referred to a unit that performs diagnostic procedures in accordance with NHS Breast Screening Programme guidance.
People in whom breast cancer is suspected are referred to a unit that carries out diagnosis in accordance with NHS Breast Screening Programme guidance.

Source clinical guideline references

NICE clinical guideline 27, recommendation 1.6.1

Data source

Structure
Manual for cancer services: breast measures (National Cancer Peer Review Programme). Available from www.cquins.nhs.uk
Process
Manual for cancer services: breast measures (National Cancer Peer Review Programme). Available from www.cquins.nhs.uk

Definitions

The NHS Breast Screening Programme implements the Best Practice Diagnostic Guidelines for Patients Presenting with Breast Symptoms (2011), which are endorsed as current policy by the Department of Health. Diagnostic procedures are performed in accordance with the Clinical Guidelines for Breast Cancer Screening Assessment Third Edition (2010), which contain diagnostic algorithms for assessment of symptomatic patients

Clinical assessment

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 early invasive breast cancer are offered a pre-treatment ultrasound evaluation of the axilla and, if abnormal lymph nodes are identified, ultrasound-guided needle biopsy (fine needle aspiration or core). Those with no evidence of lymph node involvement on needle biopsy are offered sentinel lymph node biopsy when axillary surgery is performed.

Quality measure

Structure
a) Evidence of local arrangements, including written clinical protocols, to ensure that people with early invasive breast cancer are offered a pre-treatment ultrasound of the axilla and, if abnormal lymph nodes are identified, ultrasound-guided needle biopsy (fine needle aspiration [FNA] or core).
b) Evidence of local arrangements including written clinical protocols to ensure that people with early invasive breast cancer and no evidence of lymph node involvement are offered sentinel lymph node biopsy when axillary surgery is performed.
Process
a) Proportion of people with early invasive breast cancer who receive a pre-treatment ultrasound evaluation of the axilla.
Numerator – the number of people in the denominator receiving a pre-treatment ultrasound evaluation of the axilla.
Denominator – the number of people with early invasive breast cancer.
b) Proportion of people with early invasive breast cancer who receive a pre-treatment ultrasound that identifies abnormal lymph nodes who receive an ultrasound-guided needle biopsy (FNA or core).
Numerator – the number of people in the denominator receiving an ultrasound needle biopsy (FNA or core).
Denominator – the number of people with early invasive breast cancer who receive a pre-treatment ultrasound that identifies abnormal lymph nodes.
c) Proportion of people with early invasive breast cancer and no pre-treatment ultrasound evidence of lymph node involvement who receive sentinel lymph node biopsy.
Numerator – the number of people in the denominator receiving sentinel lymph node biopsy.
Denominator – the number of people with early invasive breast cancer and no pre-treatment ultrasound evidence of lymph node involvement.
Outcome
Re-operation rates for axillary surgery.
Numerator – the number of patients in the denominator receiving more than one axillary operation to remove ipsilateral axillary lymph nodes.
Denominator – the number of patients with node-positive early invasive breast cancer who receive an axillary operation.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people with early invasive breast cancer to be offered a pre-treatment ultrasound evaluation of the axilla and, if abnormal lymph nodes are identified, ultrasound-guided needle biopsy (FNA or core). In addition, ensure systems are in place for those with no evidence of lymph node involvement to be offered sentinel lymph node biopsy when axillary surgery is performed.
Healthcare professionals ensure that people with early invasive breast cancer are offered a pre-treatment ultrasound evaluation of the axilla and, if abnormal lymph nodes are identified, ultrasound-guided needle biopsy (FNA or core). Ensure that those with no evidence of lymph node involvement are offered sentinel lymph node biopsy when axillary surgery is performed.
Commissioners ensure they commission services that provide pre-treatment ultrasound evaluation of the axilla for people with early invasive breast cancer and, if abnormal lymph nodes are identified, ultrasound-guided needle biopsy (FNA or core). Ensure services offer sentinel lymph node biopsy to those with no evidence of lymph node involvement when axillary surgery is performed.
People with early invasive breast cancer are offered an ultrasound scan of the armpit (axilla) before cancer treatment starts, to look for possible spread of the cancer to the lymph nodes. If abnormal lymph nodes are found, people are offered an ultrasound-guided needle biopsy to take a tissue sample from a lymph node. If there is no evidence of abnormal lymph nodes, people are offered another test called sentinel lymph node biopsy, which is performed during surgery for the cancer.

Source clinical guideline references

NICE clinical guideline 80, recommendations 1.1.3 and 1.4.1 (key priorities for implementation).

Data source

Structure
a) and b) Local data collection.
Process
a), b) and c) The Association of Breast Surgery (ABS) Breast Screening Audit. Available from www.cancerscreening.nhs.uk and National Cancer Dataset and Cancer Outcomes and Services Dataset (in development). Available from www.ic.nhs.uk Also contained within NICE clinical guideline 80 audit support, criteria 1 and 2. Available from guidance.nice.org.uk/CG80
Outcome
Local data collection.

Breast conserving surgery

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 early breast cancer undergoing breast conserving surgery, which may include the use of oncoplastic techniques, have an operation that both minimises local recurrence and achieves a good aesthetic outcome.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people with early breast cancer undergoing breast conserving surgery, which may include the use of oncoplastic techniques, have an operation that both minimises local recurrence and achieves a good aesthetic outcome.
Process
Proportion of people with early breast cancer who undergo breast conserving surgery.
Numerator – the number of people in the denominator who have breast conserving surgery.
Denominator – the number of people with early breast cancer having surgery.
Outcome
a) Mastectomy rates.
b) Re-operation rates after first breast conserving surgery.
c) Breast cancer local recurrence rate.
Numerator – the number of people in the denominator who have a local recurrence.
Denominator – the number of people with early breast cancer who have had breast conserving surgery.
d) Patient satisfaction with outcome of breast surgery.
Numerator – the number of people in the denominator who report satisfaction with the aesthetic outcome of breast conserving surgery.
Denominator – the number of people early breast cancer who have had breast conserving surgery.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people with early breast cancer who undergo breast conserving surgery, which may include oncoplastic techniques, to have an operation that both minimises local recurrence and achieves a good aesthetic outcome.
Healthcare professionals ensure people with early breast cancer who undergo breast conserving surgery, which may include oncoplastic techniques, have an operation that both minimises local recurrence and achieves a good aesthetic outcome. They should also record local recurrences.
Commissioners ensure they commission services that provide operations, including oncoplastic techniques, that both minimise local recurrence and achieve a good aesthetic outcome.
People with early breast cancer who have an operation to remove just the tumour and a small amount of breast tissue around it (breast conserving surgery), which may include techniques to improve appearance, have an operation that minimises the risk that the cancer will come back, as well as giving a good cosmetic appearance.

Source clinical guideline references

NICE clinical guideline 80, recommendation 1.5.1 (key priority for implementation).

Data source

Structure
Local data collection.
Process
National Mastectomy and Breast Reconstruction (MBR) Audit. Previous figures are available from www.ic.nhs.uk. This data collection ended in March 2011.
Outcome
a) and c) National Mastectomy and Breast Reconstruction (MBR) Audit. Previous figures are available from www.ic.nhs.uk. This data collection ended in March 2011.
b) and d) Local data collection.

Definitions

Breast conserving surgery may include wide excision and partial reconstruction.

Mastectomy

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 early breast cancer who are to undergo mastectomy have the options of immediate and planned delayed breast reconstruction discussed with them.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people with early breast cancer who are to undergo mastectomy have the options of immediate and planned delayed breast reconstruction discussed with them.
Process
a) Proportion of people with early breast cancer having mastectomy who have an immediate or planned delayed breast reconstruction.
Numerator – the number of people in the denominator who have an immediate or planned delayed breast reconstruction.
Denominator – the number of people with early breast cancer having mastectomy.
b) Proportion of people with early breast cancer who are to undergo mastectomy who have the options of immediate or planned delayed breast reconstruction discussed with them.
Numerator – the number of people in the denominator who have the options of immediate or planned delayed breast reconstruction discussed with them.
Denominator – the number of people with early breast cancer who are to undergo mastectomy.
Outcome
Patient satisfaction with discussion about breast surgery options.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people with early breast cancer who are to undergo mastectomy to have the options of immediate and planned delayed breast reconstruction discussed with them.
Healthcare professionals ensure they discuss the options of immediate and planned delayed breast reconstruction with people with early breast cancer who are to undergo mastectomy.
Commissioners ensure they commission services in which the options of immediate and planned delayed breast reconstruction are discussed with people with early breast cancer who are to undergo mastectomy.
People with early breast cancer who are to undergo mastectomy (an operation to remove the whole breast) have the options of immediate and planned delayed breast reconstruction discussed with them.

Source clinical guidelines

NICE clinical guideline 80, recommendation 1.5.1 (key priority for implementation).

Data source

Structure
Local data collection
Process
a) National Mastectomy and Breast Reconstruction (MBR) Audit. Previous figures are available from www.ic.nhs.uk. This data collection ended in March 2011.
b) Local data collection. Contained within NICE clinical guideline 80 audit support, criterion 3. Available from guidance.nice.org.uk/CG80
Outcome
Local data collection

Definitions

All appropriate breast reconstruction options should be offered and discussed with people, irrespective of whether they are all available locally.
People with early breast cancer who are to undergo mastectomy should have an operation that minimises local recurrence and achieves a good aesthetic outcome.

Pathology – ER and HER2 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 disease (if clinically appropriate) have the ER and HER2 status of the tumour assessed and the results made available within 2 weeks to allow planning of systemic treatment by the multidisciplinary team.

Quality measure

Structure
a) Evidence of local arrangements and written clinical protocols to ensure that people with newly diagnosed invasive breast cancer have the oestrogen receptor (ER) and human epidermal growth receptor 2 (HER2) status of the tumour assessed.
b) Evidence of local arrangements and written clinical protocols to ensure that people with recurrent disease have the ER and HER2 status of the tumour assessed if clinically appropriate.
c) Evidence of local arrangements and written clinical protocols to ensure ER and HER2 status results are available within 2 weeks to allow planning of systemic treatment by the multidisciplinary team.
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.
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.
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.
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.
e) Proportion of people with newly diagnosed invasive breast cancer or recurrent disease who have ER status results available within 2 weeks.
Numerator – the number of people in the denominator who have ER status results available within 2 weeks.
Denominator – the number of people with newly diagnosed invasive breast cancer or recurrent disease.
f) Proportion of people with newly diagnosed invasive breast cancer or recurrent disease who have HER2 status results available within 2 weeks.
Numerator – the number of people in the denominator who have HER2 status results available within 2 weeks.
Denominator – the number of people with newly diagnosed invasive breast cancer or recurrent disease.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people with newly diagnosed invasive breast cancer and those with recurrent disease (if clinically appropriate) to have the ER and HER2 status of the tumour assessed and for results to be available within 2 weeks.
Healthcare professionals ensure people with newly diagnosed invasive breast cancer and those with recurrent disease (if clinically appropriate) have the ER and HER2 status of the tumour assessed and results are available within 2 weeks.
Commissioners ensure they commission services that assess ER and HER2 status of the tumour for people with newly diagnosed invasive breast cancer and those with recurrent disease (if clinically appropriate) and ensure results are available within 2 weeks.
People with newly diagnosed invasive breast cancer and, if appropriate, those with breast cancer that has come back or spread have tissue from their tumour tested to find out its 'oestrogen receptor' (ER) and 'human epidermal growth receptor 2' (HER2) status. The test results are available within 2 weeks to help plan further treatment.

Source clinical guideline references

NICE clinical guideline 81, recommendation 1.1.8 (key priority for implementation) and NICE clinical guideline 80, recommendations 1.6.1, 1.6.3 and 1.6.4.

Data source

Structure
a), b) and c) Local data collection.
Process
a), b), c), d), e) and f) Local data collection.

Definitions

ER and HER2 status should be assessed on recurrent disease if not assessed at the time of initial diagnosis (ER will usually have been assessed at the time of initial diagnosis, unless the original diagnosis was made several years ago before testing for ER or HER2 was routine) or if it is felt the biology of the tumour may have changed.

Management

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 early invasive breast cancer, irrespective of age, are offered surgery, radiotherapy and appropriate systemic therapy, unless significant comorbidity precludes it.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people with early invasive breast cancer, irrespective of age, are offered surgery, radiotherapy and appropriate systemic therapy, unless significant comorbidity precludes it.
Process
a) Proportion of people older than 70 with early invasive breast cancer who receive breast conserving surgery.
Numerator – the number of people in the denominator who receive breast conserving surgery.
Denominator – the number of people older than 70 with early invasive breast cancer.
b) Proportion of people aged 70 and under with early invasive breast cancer who receive breast conserving surgery.
Numerator – the number of people in the denominator who receive breast conserving surgery.
Denominator – the number of people aged 70 and under with early invasive breast cancer.
c) Proportion of people older than 70 with early invasive breast cancer who receive radiotherapy after breast conserving surgery.
Numerator – the number of people in the denominator who receive radiotherapy after breast conserving surgery.
Denominator – the number of people older than 70 with early invasive breast cancer who have breast conserving surgery.
d) Proportion of people aged 70 and under with early invasive breast cancer who receive radiotherapy after breast conserving surgery.
Numerator – the number of people in the denominator who receive radiotherapy after breast conserving surgery.
Denominator – the number of people aged 70 and under with early invasive breast cancer who have breast conserving surgery.
e) Proportion of people older than 70 with early invasive breast cancer that is oestrogen-receptor (ER) positive who receive endocrine therapy.
Numerator – the number of people in the denominator who receive endocrine therapy.
Denominator – the number of people older than 70 with early invasive breast cancer that is ER-positive.
f) Proportion of people aged 70 and under with early invasive breast cancer that is ER-positive who receive endocrine therapy.
Numerator – the number of people in the denominator who receive endocrine therapy.
Denominator – the number of people aged 70 and under with early invasive breast cancer that is ER-positive.
g) Proportion of people older than 70 with early invasive breast cancer that is hormone receptor-negative who receive chemotherapy.
Numerator – the number of people in the denominator who receive chemotherapy.
Denominator – the number of people older than 70 with early invasive breast cancer that is hormone receptor-negative.
h) Proportion of people aged 70 and under with early invasive breast cancer that is hormone receptor-negative who receive chemotherapy.
Numerator – the number of people in the denominator who receive chemotherapy.
Denominator – the number of people aged 70 and under with early invasive breast cancer that is hormone receptor-negative.

Description of what the quality statement means for each audience

Service providers ensure systems and written clinical protocols are in place so that people with early invasive breast cancer, irrespective of age, are offered surgery, radiotherapy and appropriate systemic therapy, unless significant comorbidity precludes it.
Healthcare professionals ensure that people with early invasive breast cancer, irrespective of age, are offered surgery, radiotherapy and appropriate systemic therapy, unless significant comorbidity precludes it.
Commissioners ensure they commission services that offer people with early invasive breast cancer, irrespective of age, surgery, radiotherapy and appropriate systemic therapy, unless significant comorbidity precludes it.
People with early invasive breast cancer, whatever their age, are offered surgery, radiotherapy and other appropriate treatments, unless other illnesses or conditions mean it is unsuitable.

Source clinical guideline references

NICE clinical guideline 80, recommendation 1.12.1 (key priority for implementation).

Data source

Structure Local data collection.
Process
a), b) West Midlands Cancer Intelligence Unit (2007) Breast Cancer Clinical Outcome Measures (BCCOM) Project. Outcome measure 5: number and proportion of breast cancers treated surgically. Available from www.wmpho.org.uk.
c), d), e), f), g) and h) Local data collection.

Definitions

People should receive an age-independent assessment of comorbidity that includes performance status to determine the presence of significant comorbidity.
Comprehensive geriatric assessment, where a key feature is the ability to function independently without additional support, can be very valuable in deciding whether the patient can cope with adjuvant treatments.

Equality and diversity considerations

Breast cancer treatment should be based on clinical need and fitness for treatment rather than age. Treatment and care of all patients with early invasive breast cancer should take into account patients' needs and preferences.

Staging

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 early invasive breast cancer do not undergo staging investigations for distant metastatic disease in the absence of symptoms.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people with early invasive breast cancer do not undergo staging investigations for distant metastatic disease in the absence of symptoms.
Process
Proportion of people with early invasive breast cancer who do not undergo staging investigations for distant metastatic disease in the absence of symptoms.
Numerator – the number of people in the denominator who do not undergo staging investigations for distant metastatic disease.
Denominator – the number of people with early invasive breast cancer who have no symptoms suggestive of distant metastatic disease.

Description of what the quality statement means for each audience

Service providers ensure systems are in place so that people with early invasive breast cancer do not undergo staging investigations for distant metastatic disease in the absence of symptoms.
Healthcare professionals ensure that people with early invasive breast cancer do not undergo staging investigations for distant metastatic disease in the absence of symptoms.
Commissioners ensure they commission services in which people with early invasive breast cancer do not undergo staging investigations for distant metastatic disease in the absence of symptoms.
People with early invasive breast cancer do not undergo investigations for cancer elsewhere in the body if they have no symptoms that the cancer has spread.

Source clinical guideline references

Data source

Structure
Local data collection
Process
Local data collection

Definitions

Staging is indicated for inflammatory, locally advanced or recurrent breast cancer.

Adjuvant therapy planning

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 early invasive breast cancer are involved in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.

Quality measure

Structure
Evidence of local arrangements to ensure systems are in place for people with early invasive breast cancer to be involved in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
Process
Proportion of people with early invasive breast cancer who are involved in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
Numerator – the number of people in the denominator who are involved in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
Denominator – the number of people with early invasive breast cancer who have had surgery.
Outcome
Patient satisfaction with the decision-making process.

Description of what the quality statement means for each audience

Service providers ensure systems are in place to involve people with early invasive breast cancer in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
Healthcare professionals ensure that people with early invasive breast cancer are involved in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
Commissioners ensure they commission services that involve people with early invasive breast cancer in decisions about adjuvant therapy after surgery, which are based on an assessment of the prognostic and predictive factors, and the potential benefits and side effects.
People with early invasive breast cancer are involved in decisions about additional treatments after surgery. The decisions are made by reviewing the different factors that might affect the results of additional treatments, and the possible benefits and side effects.

Source clinical guideline references

NICE clinical guideline 80, recommendations 1.6.6 and 1.6.7.

Data source

Structure
Local data collection.
Process
Local data collection.
Outcome
National Cancer Patient Experience Survey Programme 2010. Available from www.dh.gov.uk

Definitions

Discussions about adjuvant therapy after surgery may be supported by the use of appropriate models to support estimates of prognosis and the benefit of adjuvant treatment. These models include, but are not limited to:
  • Adjuvant! Online
  • Nottingham Prognostic Index
  • CancerMath
  • Predict

Clinical follow-up

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 having treatment for early breast cancer are offered personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.

Quality measure

Structure
a) Evidence of local arrangements and written clinical protocols to ensure that people having treatment for early breast cancer are offered personalised information and support, including a written follow-up care plan.
b) Evidence of local arrangements to ensure that people having treatment for early breast cancer are provided with details of how to contact a named healthcare professional.
Process
Proportion of people having treatment for early breast cancer who receive personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.
Numerator – the number of people in the denominator receiving personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.
Denominator – the number of people having treatment for early breast cancer.

Description of what the quality statement means for each audience

Service providers ensure systems are in place to offer people having treatment for early breast cancer personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.
Healthcare professionals ensure people having treatment for early breast cancer are offered personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.
Commissioners ensure they commission services that offer people having treatment for early breast cancer personalised information and support, including a written follow-up care plan and details of how to contact a named healthcare professional.
People having treatment for early breast cancer are offered personalised information and support, including a written plan for their care after treatment and details of how to contact a named healthcare professional.

Source clinical guideline references

NICE clinical guideline 80, recommendation 1.14.6 (key priority for implementation).

Data source

Structure
a) and b) Local data collection.
Process
Local data collection. Contained within NICE clinical guideline 80 audit support, criterion 8. Available from http://guidance.nice.org.uk/CG80

Definitions

This statement focuses on people with early breast cancer. People with recurrent and advanced disease are addressed in statements 11 and 12.
Personalised information and support should include:
  • details of named healthcare professionals and how to contact them
  • dates of any follow-up appointments and review of ongoing adjuvant therapy (including assessment of bone density)
  • details of surveillance mammography (frequency and duration)
  • explanations of types of recurrence (ongoing risk), signs and symptoms and how to report them
  • support in coping with the fear and anxiety of recurrence
  • explanations of the incidence and of interventions for possible effects of treatment, including menopausal symptoms, fatigue, lymphoedema, pain, sleep disruption, future pregnancy and bone health
  • information about the possible psychosocial impact of breast cancer, including anxiety, depression, altered body image, sexuality and relationships
  • practical information about diet, reducing body mass index (BMI) and exercise (lifestyle changes that may help to reduce the risk of recurrence and enhance recovery), finances and work, breast prostheses and travel insurance
  • signposting to further sources of information and support.

Equality and diversity considerations

All information about treatment and care should be personalised and tailored to the individual needs of the patient (refer to the 'Diversity, equality and language' section above).

Follow-up imaging

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

Women treated for early breast cancer have annual mammography for 5 years after treatment. After 5 years, women who are 50 or older receive breast screening according to the NHS Breast Screening Programme timescales, whereas women younger than 50 continue to have annual mammography until they enter the routine NHS Breast Screening Programme.

Quality measure

Structure
a) Evidence of local arrangements and written clinical protocols to ensure that women treated for early breast cancer have annual mammography for 5 years after treatment and then, if they are 50 or older, receive breast screening according to the NHS Breast Screening Programme timescales.
b) Evidence of local arrangements and written clinical protocols to ensure that women treated for early breast cancer have annual mammography until they are 50, when they enter the routine NHS Breast Screening Programme.
Process
a) Proportion of women treated for early breast cancer and 45 or older at the time the post-treatment surveillance started, who have had 5 years of annual mammography before entering the NHS Breast Screening Programme.
Numerator – the number of women in the denominator who have had annual mammography for 5 years before entering the NHS Breast Screening Programme.
Denominator – the number of women treated for early breast cancer who were 45 or older when post-treatment surveillance started.
b) Proportion of women treated for early breast cancer and younger than 45 when post-treatment surveillance started, who have had annual mammography until they entered the NHS Breast Screening Programme at the age of 50.
Numerator – the number of women in the denominator who have had annual mammography until they entered the NHS Breast Screening Programme at the age of 50.
Denominator – the number of women treated for early breast cancer who were under 45 when post-treatment surveillance started.
c) Proportion of women treated for early breast cancer who are within 5 years of finishing their treatment who have had a mammography within the previous year.
Numerator – the number of women in the denominator who have had a mammography within the previous year.
Denominator – the number of women treated for early breast cancer who are within 5 years of finishing their treatment.

Description of what the quality statement means for each audience

Service providers ensure systems and processes are in place so that women treated for early breast cancer have annual mammography for 5 years after treatment; and that after 5 years women who are 50 or older receive breast screening according to the NHS Breast Screening Programme timescales, while women younger than 50 continue to have annual mammography until they enter the routine NHS Breast Screening Programme.
Healthcare professionals ensure that women treated for early breast cancer have annual mammography for 5 years after treatment; and that after 5 years women who are 50 or older receive breast screening according to the NHS Breast Screening Programme timescales, while women younger than 50 continue to have annual mammography until they enter the routine NHS Breast Screening Programme.
Commissioners ensure they commission services that ensure that women treated for early breast cancer have annual mammography for 5 years after treatment; and that after 5 years women who are 50 or older receive breast screening according to the NHS Breast Screening Programme timescales, while women younger than 50 continue to have annual mammography until they enter the routine NHS Breast Screening Programme.
Women treated for early breast cancer have an annual breast screen for 5 years after treatment. After 5 years women who are 50 or older have breast screening according to NHS Breast Screening Programme timings, whereas those under 50 continue with annual breast screening until they reach 50 and start screening through the NHS Breast Screening Programme.

Source clinical guideline references

NICE clinical guideline 80, recommendations 1.14.1 and 1.14.2.

Data source

Structure
a) and b) Local data collection.
Process
a), b) and c) National Cancer Dataset and Cancer Outcomes and Services Dataset (in development). Available from www.ic.nhs.uk

Equality and diversity considerations

This statement applies only to women because men are not screened for breast cancer, either routinely or following treatment for breast cancer.
Men are not screened for breast cancer because it is so rare, and those men who do have breast cancer will receive a mastectomy, which will leave no breast tissue to screen. The only circumstances in which a man with breast cancer would not receive a mastectomy are if he is not fit enough for the operation or the tumour is inoperable. In both these circumstances screening is inappropriate.

Multidisciplinary team

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 who develop local recurrence, regional recurrence and/or distant metastatic disease have their treatment and care discussed by the multidisciplinary team.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that systems are in place for the multidisciplinary team to discuss the treatment and care of all people who develop local recurrence, regional recurrence and/or distant metastatic disease.
Process
Proportion of people who develop local recurrence, regional recurrence and/or distant metastatic disease who are discussed by the multidisciplinary team.
Numerator – the number of people in the denominator whose treatment and care is discussed by the multidisciplinary team.
Denominator – the number of people who develop local recurrence, regional and/or distant metastatic disease.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for the multidisciplinary team to discuss the treatment and care of all people who develop local recurrence, regional recurrence and/or distant metastatic disease.
Healthcare professionals ensure that they discuss within the multidisciplinary team the treatment and care of all people who develop local recurrence, regional recurrence and/or distant metastatic disease.
Commissioners ensure they commission services that have systems in place for the multidisciplinary team to discuss the treatment and care of all people who develop local recurrence, regional recurrence and/or distant metastatic disease.
People with breast cancer that has spread or come back have their treatment and care discussed by a specialist breast cancer healthcare team (a multidisciplinary team).

Source clinical guideline references

NICE clinical guideline 81, recommendation 1.5.9.

Data source

Structure
Local data collection
Process
Local data collection

Definitions

This statement addresses people with recurrent and metastatic disease. All people with early disease have their treatment and care discussed by the multidisciplinary team as shown in other statements.
Multidisciplinary team discussions may include, but are not limited to:
  • oestrogen receptor (ER) and human epidermal growth receptor 2 (HER2) status
  • performance status of the patient
  • site and rate of progression of recurrent disease.

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 recurrent or advanced breast cancer have access to a 'key worker', who is a clinical nurse specialist whose role is to provide continuity of care and support, offer referral to psychological services if required and liaise with other healthcare professionals, including the GP and specialist palliative care services.

Quality measure

Structure
Evidence of local arrangements and written clinical protocols to ensure that people with recurrent and advanced breast cancer have access to a key worker, who is a clinical nurse specialist whose role is to provide continuity of care and support, offer referral to psychological services if required and liaise with other healthcare professionals, including the GP and specialist palliative care services.
Process
Proportion of people with recurrent or advanced breast cancer who have a key worker who is a clinical nurse specialist.
Numerator – the number of people in the denominator who have a key worker who is a clinical nurse specialist.
Denominator – the number of people with recurrent or advanced breast cancer.
Outcome
a) Patient satisfaction with access to a key worker.
b) Patient satisfaction with the information, support and signposting provided by the key worker.

Description of what the quality statement means for each audience

Service providers ensure people with recurrent or advanced breast cancer have access to a key worker, who is a clinical nurse specialist whose role is to provide continuity of care and support, offer referral to psychological services if required and liaise with other healthcare professionals, including the GP and specialist palliative care services.
Healthcare professionals ensure people with recurrent or advanced breast cancer have access to a key worker, who is a clinical nurse specialist whose role is to provide continuity of care and support, offer referral to psychological services if required and liaise with other healthcare professionals, including the GP and specialist palliative care services.
Commissioners ensure they commission services that provide people with recurrent or advanced breast cancer with access to a key worker, who is a clinical nurse specialist whose role is to provide continuity of care and support, offer referral to psychological services if required and liaise with other healthcare professionals, including the GP and specialist palliative care services.
People with recurrent or advanced breast cancer have access to a 'key worker' (a specialist nurse) who provides and coordinates care and support throughout their care, can refer them for psychological help if needed and is in contact with other healthcare professionals, including the GP and specialist palliative care services.

Source clinical guideline references

NICE clinical guideline 81, recommendation 1.4.1.

Data source

Structure
Local data collection.
Process
A Cancer Survivorship Survey was piloted in 2011 by the National Cancer Survivorship Initiative and contained a question about having a named nurse who patients could contact if they had a worry about their cancer care. Available from www.ncsi.org.uk
Outcome
a) and b) National Cancer Patient Experience Survey Programme 2010. Available from www.dh.gov.uk

Definitions

Adapted from 'Improving supportive and palliative care for adults with cancer' (NICE cancer service guidance, 2004):
A key worker is a clinical nurse specialist who, with the patient's consent and agreement, takes a key role in coordinating the patient's care and promoting continuity.

Brain metastases

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 who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease are referred to a neuroscience brain and other rare CNS tumours multidisciplinary team.

Quality measure

Structure
Evidence of local arrangements to ensure that people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease are referred to a neuroscience brain and other rare central nervous system (CNS) tumours multidisciplinary team.
Process
Proportion of people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease who are referred to a neuroscience brain and other rare CNS tumours multidisciplinary team.
Numerator – the number of people in the denominator referred to a neuroscience brain and other rare CNS tumours multidisciplinary team.
Denominator – the number of people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease.

Description of what the quality statement means for each audience

Service providers ensure systems are in place for people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease to be referred to a neuroscience brain and other rare CNS tumours multidisciplinary team.
Healthcare professionals ensure they refer people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease to a neuroscience brain and other rare CNS tumours multidisciplinary team.
Commissioners ensure they commission services that refer people who have a single or small number of potentially resectable brain metastases, a good performance status and who have no (or minimal) other sites of metastatic disease to a neuroscience brain and other rare CNS tumours multidisciplinary team.
People with breast cancer that has spread to the brain but nowhere else (or if spread to other areas of the body is minimal), are referred to a healthcare team specialising in brain cancer (a neuroscience multidisciplinary team).

Source clinical guideline references

NICE clinical guideline 81, recommendation 1.5.16 (key priority for implementation).

Data source

Structure
Local data collection
Process
Local data collection

Definitions

Neuroscience brain and other rare CNS tumours multidisciplinary teams are described in the National Cancer Peer Review Programme 'Manual for cancer services: Brain and CNS measures' (2011).

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Education and learning

NICE produces resources for individual practitioners, teams and those with a role in education to help improve and assess users' knowledge of relevant NICE guidance and its application in practice.

Pathway information

Patient-centred care

Patients and healthcare professionals have rights and responsibilities as set out in the NHS Constitution for England – all NICE guidance is written to reflect these. Treatment and care should take into account individual needs and preferences. People should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If the person is under 16, their family or carers should also be given information and support to help the child or young person to make decisions about their treatment. Healthcare professionals should follow the Department of Health's advice on consent. If someone does not have capacity to make decisions, healthcare professionals should follow the code of practice that accompanies the Mental Capacity Act and the supplementary code of practice on deprivation of liberty safeguards.
For young people moving between paediatric and adult services, care should be planned and managed according to the best practice guidance described in the Department of Health’s Transition: getting it right for young people.
Adult and paediatric healthcare teams should work jointly to provide assessment and services to young people. Diagnosis and management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

Updates to this pathway

30 June 2014 Link to the advanced breast cancer pathway added to complications of local treatments and menopausal symptoms.
10 June 2014 Minor maintenance updates
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 to adjuvant therapy planning. Minor maintenance updates.
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.
12 October 2012 Minor maintenance updates.
11 July 2012 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 quality standard added.
1 August 2011 Arrow on Advanced breast cancer: Endocrine therapy path corrected.

Supporting information

Glossary

Aromatase inhibitor
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
Hormone replacement therapy
Left ventricular ejection fraction
Multidisciplinary team
Magnetic resonance imaging
Supraclavicular fossa
Sentinel lymph node
Sentinel lymph node biopsy
Selective serotonin reuptake inhibitor

Paths in this pathway

Pathway created: May 2011 Last updated: June 2014

© NICE 2014

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