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Early and locally advanced breast cancer

About

What is covered

This interactive flowchart covers diagnosing and treating adults with early and locally advanced breast cancer. This includes:
  • newly diagnosed invasive adenocarcinoma of the breast of any size (T1‑T4), with or without spread to locoregional lymph nodes (N0‑N3) and with no distant metastases (M0)
newly diagnosed DCIS
  • Paget's disease of the breast.
It does not cover:
  • invasive adenocarcinoma of the breast and distant metastases (clinical or pathological M1)
  • rare breast tumours (for example, angiosarcoma, lymphoma)
  • benign breast tumours (for example, fibroadenoma)
  • phyllodes tumour
  • locally recurrent breast cancer or DCIS
  • LCIS.

Updates

Updates to this interactive flowchart

17 July 2018 Updated on publication of early and locally advanced breast cancer: diagnosis and treatment (NICE guideline NG101).
30 January 2018 Intrabeam radiotherapy system for adjuvant treatment of early breast cancer (NICE technology appraisal guidance 501) added to surgery to the breast.
22 August 2017 Liposuction for chronic lymphoedema (NICE interventional procedures guidance 588) added to lymphoedema.
21 March 2017 Recommendation on gene testing added and recommendations on receptor testing moved to receptor and gene testing.
20 December 2016 Pertuzumab for the neoadjuvant treatment of HER2‑positive breast cancer (NICE technology appraisal guidance 424) added to primary systemic and neoadjuvant therapy.
15 June 2016 Breast cancer (NICE quality standard 12) updated.
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 diagnostics 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 diagnostics guidance 8) added.
30 September 2011 Breast cancer (NICE quality standard 12) added.
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Short Text

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

What is covered

This interactive flowchart covers diagnosing and treating adults with early and locally advanced breast cancer. This includes:
  • newly diagnosed invasive adenocarcinoma of the breast of any size (T1‑T4), with or without spread to locoregional lymph nodes (N0‑N3) and with no distant metastases (M0)
newly diagnosed DCIS
  • Paget's disease of the breast.
It does not cover:
  • invasive adenocarcinoma of the breast and distant metastases (clinical or pathological M1)
  • rare breast tumours (for example, angiosarcoma, lymphoma)
  • benign breast tumours (for example, fibroadenoma)
  • phyllodes tumour
  • locally recurrent breast cancer or DCIS
  • LCIS.

Updates

Updates to this interactive flowchart

17 July 2018 Updated on publication of early and locally advanced breast cancer: diagnosis and treatment (NICE guideline NG101).
30 January 2018 Intrabeam radiotherapy system for adjuvant treatment of early breast cancer (NICE technology appraisal guidance 501) added to surgery to the breast.
22 August 2017 Liposuction for chronic lymphoedema (NICE interventional procedures guidance 588) added to lymphoedema.
21 March 2017 Recommendation on gene testing added and recommendations on receptor testing moved to receptor and gene testing.
20 December 2016 Pertuzumab for the neoadjuvant treatment of HER2‑positive breast cancer (NICE technology appraisal guidance 424) added to primary systemic and neoadjuvant therapy.
15 June 2016 Breast cancer (NICE quality standard 12) updated.
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 diagnostics 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 diagnostics guidance 8) added.
30 September 2011 Breast cancer (NICE quality standard 12) added.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Improving outcomes in breast cancer (2002) NICE cancer service guidance 1
Liposuction for chronic lymphoedema (2017) NICE interventional procedures guidance 588
Breast reconstruction using lipomodelling after breast cancer treatment (2012) NICE interventional procedures guidance 417
Image‑guided radiofrequency excision biopsy of breast lesions (2009) NICE interventional procedures guidance 308
Endoscopic mastectomy and endoscopic wide local excision for breast cancer (2009) NICE interventional procedures guidance 296
Laparoscopic mobilisation of the greater omentum for breast reconstruction (2008) NICE interventional procedures guidance 253
Endoscopic axillary lymph node retrieval for breast cancer (2005) NICE interventional procedures guidance 147
Interstitial laser therapy for breast cancer (2004) NICE interventional procedures guidance 89
Breast cancer (2011 updated 2016) NICE quality standard 12
AlignRT in breast cancer radiotherapy (2018) NICE medtech innovation briefing 157
L‑Dex U400 for lymphoedema after breast cancer treatment (2017) NICE medtech innovation briefing 111
ATEC system for vacuum‑assisted breast biopsy (2015) NICE medtech innovation briefing 43

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

Improving outcomes in breast cancer (2002) NICE guideline CSG1, page 33

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

Early and locally advanced breast cancer: diagnosis and management (2018) NICE guideline NG101, recommendation 1.1.1 and 1.1.2

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 management (NICE guideline NG101) 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 a change in receptor status will lead to a change in management.

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

Definitions of terms used in this quality statement

Clinically appropriate
Where there is a recurrence of a breast tumour and it is suspected that the ER and HER-2 status may be different to the original tumour and will lead to a change in management.
[Expert consensus]

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

Advanced breast cancer: diagnosis and treatment (2009) NICE guideline CG81, recommendation 1.5.11

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

Advanced breast cancer: diagnosis and treatment (2009) NICE guideline CG81, recommendation 1.4.1

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 has written information for the public on each of the following topics.

Pathway information

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Supporting information

Offer local treatment with mastectomy (or, in exceptional cases, breast‑conserving surgery) followed by radiotherapy to people with locally advanced or inflammatory breast cancer that has been treated with neoadjuvant chemotherapy.
Give instructions on functional exercises, which should start the day after surgery, to people with breast cancer. This should include relevant written information from a member of the breast or physiotherapy team.
Treat people with invasive breast cancer, irrespective of age, with surgery and appropriate systemic therapy, rather than endocrine therapy alone, unless significant comorbidity precludes surgery.

Rationale and impact: clinical trials and other studies

Rationale

The committee agreed, based on their clinical expertise, that continued improvement in breast cancer survival as well as post‑diagnosis quality of life needs ongoing research into new or refined treatment options to allow further optimisation of care.

Impact

Recruitment into clinical trials wherever possible is already standard practice so the recommendation is unlikely to result in a change in practice.

Rationale and impact: preserving fertility

Rationale

The committee agreed, based on their clinical expertise, that people having treatment for breast cancer should be advised about options for preserving their fertility, so cross‑referred to the existing NICE guideline on this topic.

Impact

Discussion of fertility options is already standard practice so the recommendation is unlikely to result in a change in practice.

Rationale and impact: further surgery after breast‑conserving surgery

Rationale

There was some evidence that there was a reduced risk of DCIS local recurrence if tissue margins were greater than 0 mm, so the committee recommended further surgery (re‑excision or mastectomy) to extend the margins if needed. Although there was no consistent evidence about tissue margins for invasive breast cancer, the committee agreed that further surgery should be offered.
The committee agreed that complete excision of the tumour with clear margins was essential for the high‑quality care of people with DCIS or invasive breast cancer.
Although there was evidence that aiming for wider margins reduced local recurrence, this did not improve overall survival. In addition, aiming for wider margins could lead to some people having unnecessary extra surgery. Given this uncertainty, the committee agreed the importance of personalised care and discussion to decide whether further surgery is needed.
There was not enough evidence to clearly define an optimum margin width between 0 mm and 2 mm to minimise local recurrence rates and minimise further surgery, so the committee agreed that this was an important topic for further research.

Impact

The rates of further surgery currently vary across the country. Although the committee noted that the recommendations will reinforce current best practice, there may be some centres that will need to amend their practice in order to follow these recommendations.
Full details of the evidence and the committee's discussion are in evidence review A: surgery to the breast.

Rationale and impact: negative preoperative ultrasound‑guided needle biopsy

Rationale

There was no new evidence that led the committee to change from the existing recommended practice (as recommended in the previous NICE guideline CG80) of:
  • offering axillary clearance to people with preoperatively pathologically proven involvement of the axillary lymph nodes
  • not offering axillary treatment after primary surgery to people with isolated tumour cells in their sentinel lymph nodes.
The committee agreed that current evidence shows that further axillary treatment after primary surgery does not improve survival for people with micrometastases and there are risks such as lymphoedema, therefore further treatment should not be offered to this population. There were unclear benefits and risks of further axillary treatment after primary surgery in people with only 1 or 2 sentinel lymph node macrometastases who have had breast‑conserving surgery and have been advised to have whole-breast radiotherapy and systemic therapy, so the committee agreed that the risks and benefits of further treatment should be discussed with this group.
Studies of neoadjuvant therapy were excluded from the evidence review.

Impact

The committee agreed that the recommendations will result in a minor change in practice because some centres currently use mainly surgery and may not use radiotherapy. In addition, more time may need to be factored in to plan and deliver radiotherapy treatment.
Full details of the evidence and the committee's discussion are in evidence review B: management of the positive axilla.

Rationale and impact: breast reconstruction

Rationale

There was not much good evidence, but the committee agreed that the main benefits of immediate breast reconstruction compared with delayed reconstruction are improved aesthetic satisfaction, improved symmetry, improved health‑related quality of life, lower overall rates of complications and a reduced need for further surgery. The committee agreed that in some circumstances, there are advantages to delayed reconstruction compared with immediate reconstruction (for example, reduced mastectomy flap loss, and capsular contracture). Therefore, delayed reconstruction should also be an option for women who wish to have a reconstruction after mastectomy. The committee also agreed that the option of no reconstruction should also be discussed, because this may be the preferred option for some women.
In addition, although radiotherapy can impact on outcomes after breast reconstruction, there was no consistent evidence for worse outcomes between radiotherapy delivered after immediate reconstructions compared with radiotherapy before delayed reconstructions. Therefore, the committee agreed that immediate reconstruction should be offered regardless of plans for chest wall radiotherapy.
There is little evidence regarding longer‑term outcomes and different types of reconstruction. Because of this, the committee agreed that more research is needed to understand whether immediate breast reconstruction or delayed breast reconstruction is better in women who may need postmastectomy radiotherapy.

Impact

The recommendations may result in a substantial change in practice because many centres do not routinely offer immediate breast reconstruction to all women (especially those who have been advised to have radiotherapy). The impact will depend on how many immediate reconstructions are already carried out. In addition, the uptake of immediate breast reconstruction will also depend on women's preferences. There may be cost savings associated with immediate reconstructions because fewer surgical procedures are needed (reconstruction is done at the same time as mastectomy and there are lower rates of additional symmetrisation surgery).
Full details of the evidence and the committee's discussion are in evidence review I: postmastectomy radiotherapy

Rationale and impact: receptor testing for invasive breast cancer

Rationale

There was not enough good evidence, so the committee agreed, using a formal consensus scoring system and their knowledge and experience, that PR status should be assessed for all invasive breast cancers because:
  • it will help when tailoring adjuvant therapy
  • it will reduce delays in starting treatment
  • if people are already having testing at this stage, their PR status can be assessed without them having to wait for additional test results.
The committee also agreed that ER, PR and HER2 status assessments should be requested simultaneously at the time of initial diagnosis to ensure that results are available at the initial preoperative multidisciplinary team meeting (as well as the postoperative meeting). This will avoid delays and the need for additional discussions.

Impact

Most people with invasive breast cancer have PR testing in current practice, although it is not always performed at diagnosis. The recommendations should reduce variation in practice and delays in starting treatment, and the need for pathology results to be discussed at more than 1 multidisciplinary meeting, and so may lead to a small cost‑saving.
Full details of the evidence and the committee's discussion are in evidence review C: adjuvant systemic therapy planning.

Rationale and impact: chemotherapy and endocrine therapy

Rationale

Good evidence showed that the prognostic tool PREDICT is an accurate tool to estimate prognosis and the benefits of treatment in most people.

Impact

The committee agreed that most healthcare professionals already use the PREDICT tool, so this recommendation will not mean a big change in practice.
Full details of the evidence and the committee's discussion are in evidence review C: adjuvant systemic therapy planning.

Rationale and impact: ovarian function suppression

Rationale

There was evidence that ovarian function suppression increased overall survival when combined with tamoxifen, and that women who have had chemotherapy benefited more. However, ovarian function suppression did not improve disease‑free survival. In addition, it induces a temporary menopause and can worsen the menopausal symptoms seen with tamoxifen.
Given the limited evidence of benefits and the side effects of the treatment, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women. This will help women to decide which treatment is right for them.

Impact

There is variation among centres in the use of ovarian function suppression, so the recommendations should lead to greater consistency and improve access to the treatment, even though not all women will wish to have it. There will be an increase in required resources for centres that do not currently provide ovarian function suppression, because additional appointments will be needed to administer the medication and monitor side effects. However, this was not anticipated to be a substantial cost increase because of the number of centres already offering ovarian function suppression. Further, increased costs will be at least partially offset by improvements in survival outcomes.
Full details of the evidence and the committee's discussion are in evidence review D: endocrine therapy for invasive disease.

Rationale and impact: extended endocrine therapy

Rationale

Good evidence showed that switching to an aromatase inhibitor after 5 years of tamoxifen improved disease‑free survival compared with postmenopausal women who had only received tamoxifen for 5 years, with the benefits being greater in those women who had a greater risk of disease recurrence.
The evidence showed no benefit in terms of disease‑free survival or overall survival from continuing tamoxifen beyond 5 years. However, some of the studies on tamoxifen were conducted in the 1980s and may not be relevant to current practice. In the committee's experience, continuing tamoxifen can be beneficial for some women.
However, evidence showed that being on endocrine therapy for more than 5 years can increase the risk of problems such as endometrial cancer, osteoporosis, toxicity and phlebitis. The committee agreed that people will often prioritise survival even if this means they will have a reduced quality of life, but that people need to be informed about the possible benefits and risks so they can make a choice.
Because of the risk of problems with taking endocrine therapy for more than 5 years, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women to help them make an informed choice about treatment, based on their own risk factors.

Impact

Some centres already review treatment at 5 years, and continue endocrine therapy with tamoxifen or an aromatase inhibitor when it could benefit women. Because a large number of women will be affected by these recommendations, the resource impact will be large for centres that are not currently providing treatment after 5 years.
Full details of the evidence and the committee's discussion are in evidence review D: endocrine therapy for invasive disease.

Rationale and impact: ductal carcinoma in situ

Rationale

There was good evidence that tamoxifen after breast‑conserving surgery for ER‑positive DCIS improved disease‑free survival and reduced rates of local recurrence in women who did not have radiotherapy. Because of their concerns about over‑treatment, the committee agreed that women who were at higher risk (those who should have had radiotherapy, but who did not receive it) would benefit more. There was no evidence available for aromatase inhibitors; however, the committee agreed they would likely produce similar improvements in disease‑free survival and reductions in local recurrence as tamoxifen. Therefore, the committee recommended endocrine therapy, rather than specifically tamoxifen.
The committee agreed that the benefits and risks of endocrine therapy should be discussed with the woman because of the potential treatment‑related complications such as menopausal symptoms, and the impact on family planning.

Impact

Offering endocrine therapy after initial treatment of DCIS will be a change of practice because it is not currently routinely offered to these women. However, because of the small number of people with DCIS who will not receive radiotherapy, and the low cost of the medicines, the committee agreed that the impact will not be significant.
Full details of the evidence and the committee's discussion are in evidence review D: endocrine therapy for invasive disease.

Rationale and impact: adjuvant chemotherapy for invasive breast cancer

Rationale

There was good evidence of improved survival when taxanes are added to anthracycline‑based chemotherapy in people with node‑positive and node‑negative breast cancer. In both groups, the benefits and risks of treatment should be discussed because of the potential side effects associated with taxanes. Three-weekly docetaxel was identified as a regimen with potentially more toxicity than weekly or fortnightly paclitaxel.

Impact

These recommendations may result in a substantial change in practice because of increased taxane use, particularly for people with node‑negative breast cancer and comorbidities.
In addition, there will be an increase in weekly and fortnightly chemotherapy regimens being offered (for people who cannot tolerate 3‑weekly regimens). These regimens have a higher cost because they are more resource intensive, and may affect capacity in chemotherapy services.
Full details of the evidence and the committee's discussion are in evidence review E: adjuvant chemotherapy.

Rationale and impact: adjuvant trastuzumab for people with T1a and T1b HER2‑positive invasive breast cancer

Rationale

There was evidence that adjuvant trastuzumab can improve disease‑free survival and overall survival in some people with T1a and T1b HER2‑positive invasive breast cancer who were treated with adjuvant trastuzumab and chemotherapy. However, only a small number of people will benefit from this treatment and, because trastuzumab can cause heart problems, it is important to avoid offering it to people who do not need it. Because of this, the committee agreed that adjuvant trastuzumab should be an option for women with T1a and T1b tumours rather than a standard treatment.
Combined chemotherapy and trastuzumab was not found to be cost effective when compared to chemotherapy alone. However, the committee agreed that it was more appropriate to compare combined chemotherapy and trastuzumab with no treatment, because these are the strategies that are likely to be used in clinical practice. Because it is the HER2‑positivity that increases risk of recurrence for people with small (T1a and T1b) tumours, it does not make sense from a clinical perspective to not treat the component that is increasing risk (that is, trastuzumab treatment for HER2‑positivity). Further, the effect of chemotherapy alone in the economic model may be overestimated because the data may not fully reflect the population under consideration.

Impact

Currently, T1 tumours are not routinely treated with adjuvant trastuzumab, so this recommendation will lead to a change in practice. However, the committee agreed that the number of additional people having treatment would be small and so the impact on current practice would be minor and unlikely to require a substantial increase in resources.
Full details of the evidence and the committee's discussion are in evidence review F: adjuvant biological therapy.

Rationale and impact: adjuvant bisphosphonate therapy

Rationale

There was good evidence that treatment with sodium clodronate and zoledronic acid improved disease-free and overall survival in postmenopausal women with node-positive invasive breast cancer.
There was little evidence of benefit for other bisphosphonates. The committee recommended considering zoledronic acid or sodium clodronate treatment for other high-risk populations (such as postmenopausal women with node-negative invasive breast cancer and a high risk of recurrence), based on the evidence that sodium clodronate has overall survival benefits in mixed populations.
Although there is evidence that IV bisphosphonates have a higher risk of osteonecrosis of the jaw, oral bisphosphonates have a higher risk of gastrointestinal problems. There is also a risk of atypical femoral fractures and osteonecrosis of the external auditory canal with bisphosphonates. Because each drug and regimen has different risks, the potential benefits and risks should be discussed with women to help them make an informed choice.
There was little evidence on survival, particularly for premenopausal women on ovarian suppression, those with node-positive or node-negative disease, and those with positive or negative oestrogen or progestogen statuses. There was not enough evidence to make a recommendation relating to the use of adjuvant bisphosphonates in premenopausal women. The committee agreed that further research is needed to determine the long-term survival benefits and the groups of people most likely to benefit from adjuvant bisphosphonates.
The committee did not look at the evidence relating to the use of bisphosphonates for bone health or for the use of baseline DEXA scanning, so did not make any new recommendations.

Impact

Bisphosphonates are not consistently offered as adjuvant treatment, so this recommendation may lead to an increase in prescribing.
GPs may need to monitor people taking oral bisphosphonates, but this is likely to be an annual review so would not have a large workload impact. However, people may make more GP visits if they have side effects from bisphosphonate treatment.
The committee agreed that IV bisphosphonates would usually be administered at the same time as chemotherapy drugs for the first 6 months of treatment, so this would not result in extra hospital visits for this period. After that, extra visits for administration and monitoring may be needed.
Full details of the evidence and the committee's discussion are in evidence review G: adjuvant bisphosphonates.

Rationale and impact: radiotherapy techniques

Rationale

There was good evidence that radiotherapy to the internal mammary nodes reduced locoregional recurrence and improved survival. However, the committee took into account the potential for lung and heart toxicity, so recommended using a radiotherapy technique that minimises this risk.
Deep inspiratory breath‑hold radiotherapy techniques
There was evidence that deep inspiratory breath‑hold radiotherapy techniques reduce the mean radiotherapy heart dose for adults with left‑sided invasive breast cancer receiving whole-breast radiotherapy. The committee did not identify any harms. There was also evidence that deep inspiration breath‑hold radiotherapy techniques did not reduce the target coverage of whole-breast radiotherapy.
There was no evidence about the use of deep inspiration breath‑hold radiotherapy techniques for people with right‑sided breast cancer, so the committee did not make separate recommendations for this subgroup.

Impact

This recommendation is likely to need a change in practice for many centres. There will be some impact on resources in order to implement this recommendation because additional training will be needed and local protocols will need developing. However, the long‑term impact on resources will be minimal: some additional planning time will be needed but there is no impact on the length or number of radiotherapy sessions.
Deep inspiratory breath‑hold radiotherapy techniques
Currently, deep inspiratory breath‑hold radiotherapy techniques are not routinely offered to people with invasive breast cancer having whole-breast radiotherapy. However, the committee noted that the Royal College of Radiologists has produced consensus statements that advise using this technique, and that many centres already offer it.
The recommendation will ensure consistent practice and ensure that people can access the best care.
Full details of the evidence and the committee's discussion are in evidence review H: breast radiotherapy.

Rationale and impact: whole-breast radiotherapy and omitting radiotherapy after breast‑conserving surgery

Rationale

There is evidence that whole-breast radiotherapy after breast‑conserving surgery reduces the risk of recurrence and increases overall survival. It also decreases rates of depression and anxiety.
However, because the risk of breast cancer recurring at 5 years is very low and there are harms associated with radiotherapy, the benefits of radiotherapy for women with a very low risk of recurrence are less certain. For these women, the committee agreed that healthcare professionals should fully discuss the benefits and risks with women before a decision is made.

Impact

Most women are already offered radiotherapy after breast‑conserving surgery so this reflects current practice, but more time may be needed to discuss the balance of benefits and risks with women.
Full details of the evidence and the committee's discussion are in evidence review H: breast radiotherapy.

Rationale and impact: partial breast radiotherapy after breast‑conserving surgery

Rationale

Good evidence showed that partial breast radiotherapy led to similar results to whole-breast radiotherapy after breast‑conserving surgery in women with a low risk of local recurrence. In addition, it may have fewer treatment‑related adverse effects. There was evidence for multicatheter interstitial brachytherapy but this was not recommended because it is not currently available in England.

Impact

The committee was aware that current practice for external beam partial breast radiotherapy after breast‑ conserving surgery is based on the Royal College of Radiologists' 2016 consensus statement, so there would be no change to recommended practice.
Full details of the evidence and the committee's discussion are in evidence review H: breast radiotherapy.

Rationale and impact: radiotherapy after mastectomy

Rationale

The committee agreed that adjuvant postmastectomy radiotherapy should be offered to people who have macroscopically node‑positive invasive breast cancer or have involved resection margins. This is because the evidence showed a beneficial effect on survival and local recurrence. Although the evidence was limited and the committee acknowledged that radiotherapy is associated with lung and cardiac morbidity, they concluded that for this group of women, the benefits of radiotherapy outweigh the harms.
There was evidence of a beneficial effect of postmastectomy radiotherapy on local recurrence and overall survival for people with node‑negative invasive breast cancer. However, the committee agreed that there was a risk of over‑treatment if all people with node‑negative invasive breast cancer received postmastectomy radiotherapy. Therefore, the committee recommended that adjuvant postmastectomy radiotherapy should be considered for people with node‑negative T3 or T4 invasive breast cancer. There was no evidence for this specific subgroup but they would be considered at increased risk of recurrence and mortality relative to smaller, node‑negative invasive breast cancers because of the size of the tumour.
The committee agreed that radiotherapy after mastectomy should not be offered to women with early invasive breast cancer who are at low risk of local recurrence (for example, most women who are lymph node‑negative) because the evidence showed limited benefit in survival and local recurrence.

Impact

The committee agreed that the recommendations will reinforce current practice, so there would be little change in practice.
Full details of the evidence and the committee's discussion are in evidence review I: postmastectomy radiotherapy.

Rationale and impact: radiotherapy to internal mammary nodes

Rationale

There was good evidence that radiotherapy to the internal mammary nodes reduced locoregional recurrence and improved survival. However, the committee took into account the potential for lung and heart toxicity, and agreed the importance of using a radiotherapy technique that minimises this risk.

Impact

This recommendation is likely to need a change in practice for many centres. There will be some impact on resources in order to implement this recommendation because additional training will be needed and local protocols will need developing. However, the long‑term impact on resources will be minimal: some additional planning time will be needed but there is no impact on the length or number of radiotherapy sessions.
Full details of the evidence and the committee's discussion are in evidence review H: breast radiotherapy.

Rationale and impact: neoadjuvant chemotherapy

Rationale

There was good evidence to say that having chemotherapy before surgery (neoadjuvant chemotherapy) enables some women to have breast‑conserving surgery who would otherwise have had total removal of their breast. The committee agreed that the response to neoadjuvant therapy could help to guide the choice of subsequent adjuvant therapy.
Platinum‑containing regimens
There was evidence that platinum‑containing neoadjuvant chemotherapy regimens can improve pCR rate and breast conservation rate in people with triple-negative invasive breast cancer. However, the committee took into account that platinum‑containing regimens can cause anaemia, thrombocytopenia, neutropenia and febrile neutropenia, and bone marrow problems and renal problems in older people. The committee agreed that healthcare professionals should have a full discussion with people about the benefits and risks of these regimens.
There was no evidence on people with the BRCA germline mutation, so the committee did not make separate recommendations for this subgroup.

Impact

The committee agreed that the recommendations would not result in a major change in practice because neoadjuvant chemotherapy is already offered in many centres. These recommendations will help improve consistency in practice.
Platinum‑containing regimens
Currently, platinum‑containing neoadjuvant chemotherapy is not routinely offered to people with triple‑negative early and locally advanced breast cancer, although the committee was aware that some centres may offer it. The recommendations will therefore bring a change in practice and will make practice more consistent across the NHS. The committee estimated that approximately 30‑40% of people receiving neoadjuvant chemotherapy may be affected by this recommendation.
Full details of the evidence and the committee's discussion are in evidence review J: neoadjuvant treatment of early and locally advanced breast cancer.

Rationale and impact: neoadjuvant endocrine therapy

Rationale

For postmenopausal women, there was some evidence that breast conservation rates, changes in tumour size and overall survival are the same with neoadjuvant endocrine therapy and neoadjuvant chemotherapy. Endocrine therapy is safer and has fewer side effects than chemotherapy, but there was not enough evidence to recommend endocrine therapy over chemotherapy for every woman. The committee agreed that healthcare professionals should discuss the potential benefits and risks with women, to help them decide which treatment is right for them and that more research is needed to say whether neoadjuvant endocrine therapy is as effective as neoadjuvant chemotherapy.
The evidence for premenopausal women showed that neoadjuvant chemotherapy was more effective than endocrine therapy, but that endocrine therapy may be effective in some women. However, some women may prefer endocrine therapy because it is safer and has fewer side effects. Because of this, the committee agreed that healthcare professionals should discuss the potential benefits and risks with women, to help them decide which treatment is right for them. The committee agreed that more research is needed on the long‑term safety of neoadjuvant endocrine therapy, and to identify which premenopausal women will benefit from it.

Impact

Neoadjuvant endocrine therapy is already being used, although there may be an increase in the number of people being offered it.
Full details of the evidence and the committee's discussion are in evidence review J: neoadjuvant treatment of early and locally advanced breast cancer.

Rationale and impact: radiotherapy after mastectomy and neoadjuvant chemotherapy

Rationale

There was not enough evidence to recommend subgroups of women in whom postmastectomy radiotherapy could be safely omitted after neoadjuvant chemotherapy. Therefore, the committee agreed that the recommendations for postmastectomy radiotherapy among people who have not received neoadjuvant chemotherapy applied to this population.
People with node‑negative T4 cancer were not included in this review because they are covered by the recommendation from the previous guideline which has been retained.
Women who respond well to neoadjuvant chemotherapy may derive less benefit from radiotherapy, but the committee agreed that further research was required to determine if the risks of radiotherapy outweighed the benefits in some women.

Impact

The committee noted that decisions about postmastectomy radiotherapy after neoadjuvant chemotherapy are currently based on pretreatment investigations, so there will be no change to practice.
Full details of the evidence and the committee's discussion are in evidence review J: neoadjuvant treatment of early and locally advanced breast cancer.

Rationale and impact: risk of developing lymphoedema

Rationale

Good evidence showed that there is no increased risk of lymphoedema associated with maintaining exercise levels after axillary intervention, so the committee agreed that people should not restrict or avoid physical activity.
Although the evidence was limited and mixed, the committee concluded that there is no consistent evidence of increased risk of lymphoedema associated with air travel, travel to hot countries, manicures, hot‑tub use, sports injuries, or medical procedures on the treated side.

Impact

Advice about preventing lymphoedema is already being provided as part of routine care, so there is unlikely to be much change in practice. However, the recommendation will lead to greater consistency in the advice offered. It should also reduce inequality and improve the quality of standard care if people who have had axillary treatment need immunisations or elective procedures.
Full details of the evidence and the committee's discussion are in evidence review B: management of the positive axilla.

Rationale and impact: lifestyle

Rationale

There was evidence that both dietary changes (reducing fat intake and maintaining a healthy weight) and physical activity increase survival in people with invasive breast cancer.
There was some evidence that cancer recurrence is more likely in people who drink more than 3 or 4 alcoholic drinks per week or 6 g of alcohol per day. This equates to approximately 5 units of alcohol per week.
There was no evidence that smoking cessation reduces recurrence of breast cancer, although the view of the committee was that smoking cessation should always be recommended to people with breast cancer.

Impact

The committee discussed that many NHS services would already be advising people with breast cancer about the importance of a healthy lifestyle, and how they can make lifestyle changes to reduce the risk of recurrence. The committee agreed that these recommendations will help to direct conversations towards effective lifestyle changes. There will be no impact on resources because these discussions were already happening, and most of the lifestyle changes will be 'self‑care' and implemented by patients themselves.
Full details of the evidence and the committee's discussion are in evidence review K: lifestyle.

Breast reconstruction options for women who choose breast reconstruction

Immediate breast reconstruction
Delayed breast reconstruction
Definition
Reconstruction is started in the same operation as the mastectomy.
After a mastectomy, reconstruction is done in a separate operation.
Number and timing of operations
For both types, more than 1 operation is usually needed to complete the reconstruction. The total number of operations will vary. It may be affected by factors such as:
  • type of reconstruction (for example, some are planned in stages; a prosthesis may be worn until reconstruction is complete)
  • personal preferences (such as whether a nipple reconstruction is requested).
Fewer operations may be needed.
More operations may be needed.
Breast reconstruction options available
These will vary depending on personal preferences (such as breast size desired), current body shape, other health conditions, previous operations and lifestyle factors (such as hobbies).
Not all hospitals or surgeons can offer all procedures. Travel to a different hospital may be needed for a specific option.
Options may be available that spare or preserve the breast skin (which may mean less scarring and a more natural look).
Limited time to make a decision about options (which may include not having a reconstruction) before surgery.
Certain options that spare or preserve the breast skin may not be available.
More time to make a decision (which may include not having a reconstruction) and to plan reconstruction.
Benefits
Breast shape remains, which may have psychological benefits.
Lifestyle changes (such as losing weight and taking regular exercise) may be possible, which increase the options and lower the risks of reconstruction surgery.
Procedures (and associated recovery) can be planned around other commitments.
Risks
Surgical complications can occur after any breast reconstruction and will vary by type of procedure and personal risk factors.
May be lower rates of:
  • tissue breakdown
  • surgery for flap removal if it cannot be used because of a complication (which may lead to delayed reconstruction and flat appearance for a period of time)
  • procedures to improve symmetry.
Complications from the mastectomy or axillary surgery can occur during the recovery period.
May be lower rates of:
  • mastectomy site complications
  • flap or implant failure (which may lead to delayed reconstruction and flat appearance for a period of time)
  • capsular contracture (a scar layer around the implant that may lead to pain if severe).
May need to interrupt hormone therapies (tamoxifen) for further surgery.
Satisfaction
No clear differences in satisfaction with completed reconstructions.
Reconstruction and adjuvant therapy (including radiotherapy and chemotherapy)
Radiotherapy or chemotherapy can be given but may be delayed if there are complications from the mastectomy or reconstruction.
Immediate reconstructions using implants may be more affected by radiotherapy than immediate flap reconstructions.
May need adaptions to scans if a tissue expander is used. For example, may not be able to have MRI scans and may need modified radiotherapy planning.
Complications can also occur after mastectomy alone, which may delay chemotherapy or radiotherapy.

Effects of extended endocrine therapy

Extended tamoxifen therapy (after an initial 5 years of tamoxifen therapy)
Extended endocrine therapy with an aromatase inhibitor (after 5 years of tamoxifen therapy)
Definition
Continuing to take tamoxifen after 5 years of tamoxifen therapy.
Switching to an aromatase inhibitor after 5 years of tamoxifen therapy.
Who can take this therapy
Premenopausal or postmenopausal women with ER‑positive invasive breast cancer.
Postmenopausal women with ER‑positive invasive breast cancer.
Effect on breast cancer recurrence
NOTE: the benefit for an individual person will depend on the risk of their cancer returning. For people with a low risk of recurrence, the benefits may not outweigh the risks or side effects.
Medium or high risk may include people who have lymph node‑positive breast cancer, with tumours that are T2 or greater and higher grade. Low risk may include people with lymph node‑negative breast cancer, with smaller or lower‑grade tumours.
Lower rates of breast cancer recurrence compared with 5 years of tamoxifen therapy.
Lower rates of breast cancer recurrence compared with 5 years of tamoxifen therapy.
In postmenopausal women, switching to an aromatase inhibitor may be more effective at reducing recurrence than continuing with tamoxifen.
Side effects
NOTE: These are common side effects experienced during additional years taking endocrine therapy. Most effects are reversible when tablets are stopped.
Side effects of endocrine therapy will continue for additional years (for example, menopausal symptoms such as hot flushes).
With extended use of tamoxifen: increased risk of thrombosis and endometrial cancer, and possibly bone density loss in premenopausal women.
Side effects of endocrine therapy will continue for additional years (for example, menopausal symptoms such as hot flushes).
With extended use of aromatase inhibitors: bone density loss, and joint and muscle pain.
Fertility and family planning
Effects on fertility and family planning will continue for additional years as women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby.
Not applicable as postmenopausal women only.

Effects of endocrine therapy after breast‑conserving surgery for women with ER‑positive DCIS

Endocrine therapy after breast‑conserving surgery for women with ER‑positive DCIS
Definition
Tamoxifen or an aromatase inhibitor for 5 years. Taken as a once‑daily tablet.
Effect on survival and disease recurrence
NOTE: The benefit for an individual person will depend on the risk of their cancer returning. For people with low risk of recurrence, the benefits may not outweigh the risks or side effects.
Risk can be estimated using a range of standardised tools and clinical expertise.
No effect on how many women are alive 5 and 10 years after diagnosis.
Lower rate of recurrence of DCIS and lower rate of invasive breast cancer, compared with women who did not receive endocrine therapy or radiotherapy after surgery.
Side effects
All endocrine therapies: menopausal symptoms such as hot flushes.
For tamoxifen: increased risk of thrombosis, endometrial cancer and possibly bone density loss in premenopausal women.
For aromatase inhibitors: joint and muscle pain, urogenital symptoms and bone density loss.
Fertility and family planning
Effects on fertility and family planning as women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby.

Benefits and risks of adding a taxane to anthracycline‑containing regimens and comparison of different taxane regimens

Effect of adding a taxane to an anthracycline containing regimen
3‑weekly docetaxel
Weekly or fortnightly paclitaxel
Effect on survival
NOTE: the benefit for an individual person will depend on the risk of their cancer returning. For people with low risk of recurrence the benefits may not outweigh the risks or side effects.
Risk can be estimated using a range of standardised tools and clinical expertise.
Some evidence for improved outcomes including reducing the risk of breast cancer returning and increasing the chance of surviving.
Benefits
Smaller doses of anthracyclines can be used, which can reduce the risk of side effects such as nausea and vomiting.
Smaller cumulative doses of individual drugs may reduce long‑term side effects, for example, cardiac toxicity and risk of second malignancies.
Side effects
Additional side effects may include joint and muscle pain, nerve damage, higher rates of febrile neutropenia and hypersensitivity reactions.
Some people have long‑term hair loss (alopecia) after treatment with taxanes.
Additional side effects may include nerve damage and hypersensitivity reactions but febrile neutropenia is less likely than with 3‑weekly docetaxel.
Some people have long‑term hair loss (alopecia) after treatment with taxanes.
Weekly paclitaxel is tolerated best, but even fortnightly is better tolerated than 3‑weekly docetaxel.
Administration
Visits to hospital every 3 weeks.
Visits to hospital every week or every 2 weeks.
Length of course
9 to 12 weeks (3 to 4 cycles).
9 to 12 weeks (9 to 12 doses)

Benefits and risks of radiotherapy compared with no radiotherapy in the group of women at low risk

Radiotherapy
No radiotherapy
Effect on local recurrence
On average, in 1,000 women, over 5 years local recurrence occurs in about 10 women, and does not occur in about 990 women.
On average, in 1,000 women, over 5 years local recurrence occurs in about 50 women, and does not occur in about 950 women.
Effect on survival
No difference in overall survival at 10 years.
No difference in overall survival at 10 years.
Risks
Possibility of short‑term and long‑term adverse effects on the breast, and resulting cosmetic changes (such as skin soreness, changes to colour of skin, radiation fibrosis or stiffening of the breast tissue).
No short‑ or long‑term adverse effects on the breast, or cosmetic changes.
Side effects
In this group of women at low risk, there is no increase in serious late side effects of radiotherapy (such as congestive cardiac failure, myocardial infarction or secondary cancer).
No side effects of radiotherapy will occur.
Administration
Given at the treatment centre 5 days a week for 3 weeks after surgery.
No need to attend the treatment centre for radiotherapy sessions.

Benefits and risks of adding a platinum to anthracycline‑containing neoadjuvant chemotherapy for triple‑negative invasive breast cancer

Effect of adding a platinum to anthracycline‑containing (with or without taxane) neoadjuvant chemotherapy
Effect on breast conservation rate
Adding a platinum improves response rates compared with anthracycline‑based (with or without taxane) chemotherapy. This may mean that some women who would otherwise need a mastectomy can be offered breast‑conserving surgery.
Effect on pathological complete response rate (no residual cancer found at surgery)
Adding a platinum improves the chances of all signs of cancer disappearing in both the breast and lymph nodes in the armpit, compared with anthracycline‑based (with or without taxane) neoadjuvant chemotherapy.
Effect on survival
No increase in overall survival with platinum‑based chemotherapy.
Side effects
NOTE: Platinum‑based therapy is only suitable for fit patients with no significant comorbidities.
Adding a platinum may mean that side effects are more severe. Anaemia, thrombocytopenia, neutropenia and febrile neutropenia are seen more frequently with platinum‑based chemotherapy.
On average, if 1,000 women with triple-negative breast cancer receive platinum‑containing neoadjuvant chemotherapy, about 70 additional women would experience severe or life‑threatening side effects compared with non‑platinum neoadjuvant chemotherapy.
Bone marrow suppression and renal problems are likely in older people.
Licensed status
At the time of publication (July 2018), platinums did not have UK marketing authorisation for this indication.

Benefits and risks of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy

Neoadjuvant endocrine therapy
Neoadjuvant chemotherapy
Definition
Tamoxifen or an aromatase inhibitor started before surgery.
Only an option for women with ER‑positive breast cancer.
Chemotherapy given before surgery.
Only an option for people who would be recommended adjuvant (after surgery) chemotherapy.
Administration
Tablet taken once a day at home.
Intravenous administration in hospital, as an outpatient.
Effectiveness
For postmenopausal women: may be as effective as neoadjuvant chemotherapy in terms of breast conservation rates and shrinking the tumour.
For premenopausal women: less effective than neoadjuvant chemotherapy at shrinking the tumour (but some tumours may respond so may be effective in some women).
For postmenopausal women: effective at improving breast conservation rates and shrinking the tumour.
For premenopausal women: more effective than endocrine therapy at shrinking the tumour.
Potential disadvantages
If neoadjuvant endocrine therapy is not effective then women may proceed to surgery earlier or may still need to have chemotherapy, either before or after surgery.
Side effects
All endocrine therapies: menopausal symptoms such as hot flushes.
For tamoxifen: increased risk of thrombosis and endometrial cancer.
For aromatase inhibitors: joint and muscle pain, urogenital symptoms, bone density loss (may also occur with tamoxifen in premenopausal women).
Side effects are usually reversible.
May allow women to avoid the additional side effects of chemotherapy (although women may still need adjuvant chemotherapy after surgery).
Side effects may include nausea and vomiting, risk of infections which may be life threatening, fatigue, neuropathy, cardiac toxicity, diarrhoea, constipation, sore mouth, skin and nail changes, risk of blood clots, risk of second malignancies, fluid retention, allergic reactions and hair loss.
Side effects may persist long term.
Fertility and family planning
Women should not become pregnant while taking tamoxifen, or within 2 months of stopping, because it may have adverse effects on the baby.
Often causes temporary infertility.
May cause permanent infertility
Length of course
May take longer than chemotherapy to shrink the tumour enough for breast‑conserving surgery.
The duration of neoadjuvant chemotherapy is shorter than neoadjuvant endocrine therapy.

Glossary

axillary lymph node dissection (also known as axillary clearance)
bone mineral density
Breast Test Wales Screening Programme
ductal carcinoma in situ
dual energy X‑ray absorptiometry
oestrogen receptor
human epidermal growth factor 2
hormone replacement therapy
intravenous
lobular carcinoma in situ
left ventricular ejection fraction
NHS Breast Screening Programme
Nottingham Prognostic Index
pathological complete response
progesterone receptor
sentinel lymph node biopsy
ER, PR, HER2 negative breast cancer
ER, PR, HER2 negative invasive breast cancer

Paths in this pathway

Pathway created: May 2011 Last updated: October 2018

© NICE 2018. All rights reserved. Subject to Notice of rights.

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