Guideline title

Familial breast cancer: classification and care of women at risk of familial breast cancer in primary, secondary care and tertiary care

Short title

Familial breast cancer

Background

1. The National Institute for Clinical Excellence (‘NICE’ or ‘the Institute’) has commissioned the National Collaborating Centre for Primary Care to develop a clinical guideline on the classification and care of women at risk of familial breast cancer for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and Welsh Assembly Government (see Appendix). The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness.
2. The Institute’s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Institute after an NSF has been issued will have the effect of updating the Framework.

Clinical need for the guideline

1. Familial breast cancer typically occurs in women within a family where there have been an unusually high number of family members affected by breast cancer. If there have been more cases of breast or related cancers than would be expected by chance alone, it may be that genes transmitted between generations are sufficient to cause or, more typically, contribute to the development of breast cancer. Environmental factors will also usually contribute to the development of breast cancer. Familial clustering may therefore be the result of chance, an increase in genetic susceptibility, a common lifestyle and/or environmental factors. For these women, the degree of risk of developing breast cancer varies according to the:

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   nature of the family history

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   number of relatives who have developed breast cancer

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   age at which the relative(s) developed breast cancer

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   age of the individual concerned.

2. The lifetime risk of developing breast cancer is about 11% for the British female population. Women with female relatives who have or have had breast cancer may have a higher risk. The possibility of identifying those women at increased risk has implications for the ability to prevent or reduce morbidity

The guideline

1. The guideline development process is described in detail in three booklets that are available from the NICE website (see ‘Further information’). The Guideline Development Process – Information for Stakeholders describes how organisations can become involved in the development of a guideline.
2. This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health and Welsh Assembly Government (see Appendix).
3. The areas that will be addressed by the guideline are described in the following sections

Population

The guideline will include a limited epidemiological overview together with a discussion of the genetic influences in familial breast cancer.

Healthcare setting

1. The guideline will cover the care received from primary, secondary and tertiary healthcare professionals who are involved in the care of women who present with an increased risk, real or perceived, of developing breast cancer.
2. The guideline will also be relevant to the work, but will not cover the practice, of those concerned with breast screening services and the identification of ovarian cancer.

Clinical management

The guideline will include recommendations on the following areas.

1. Assessment of risk of breast cancer, including the need for genetic tests and the interpretation of the results.
2. Cascade testing, or surveillance, for women at increased risk.
3. Classification and care of women at risk of familial breast cancer in breast cancer screening programmes. (See note in [d] on recommendations regarding the use of pharmacological interventions.)
4. Management plans including psychological support. Advice on treatment options will be based on the best evidence available to the Guideline Development Group. When referring to pharmacological treatments, the guideline will normally recommend use within the licensed indications. Exceptionally, and only where the evidence supports it, the guideline may recommend use outside the licensed indications. The guideline will expect that prescribers will use the Summary of Product Characteristics to inform their prescribing decisions for individual patients.
5. Referral.
6. Patient/family/carer information and support. Women covered by this guideline include family members who are concerned they may be at increased risk of familial breast cancer.

Audit support within guideline

The guideline will be accompanied by level 2 audit review criteria and advice