Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.
The grades of recommendations (A-D; SIGN 29) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.
Diagnosis, Referral and Investigation
C - Women should be encouraged to become aware of the feel and shape of their breasts, so that they are familiar with what is normal for them. (SIGN 29)
C - Women should be encouraged to report any change from normal to their general practitioner. (SIGN 29)
Investigation of Symptomatic Breast Cancer
B - All patients should have a full clinical examination. (SIGN 29)
B - Where a localised abnormality is present, patients should have imaging usually followed by fine needle aspirate cytology or core biopsy. (SIGN 29)
B - A lesion considered malignant following clinical examination, imaging, or cytology alone should, where possible, have histopathological confirmation of malignancy before any definitive surgical procedure takes place (e.g., mastectomy or axillary clearance). (SIGN 29)
D - Patients should be seen at a one-stop, multidisciplinary clinic involving breast clinicians, radiologists, and cytology.
C - Clear lines of communication should be maintained between the primary care team and staff in the breast unit. (SIGN 29)
C - The general practitioner (GP) should be made aware of the information given to the patient and relatives. (SIGN 29)
A - Psychological support should be available to women diagnosed with breast cancer at the clinic.
C - Centres and units should develop an integrated network of cancer care using common clinical guidelines, management protocols, and strategies of care. (SIGN 29)
Imaging of Symptomatic Disease
B - In patients with symptomatic disease, two-view mammography should be performed as part of triple assessment (clinical assessment, imaging, and tissue sampling) in a designated breast clinic. (SIGN 29)
B - Mammography is not recommended in women under the age of 35 years unless there is a strong suspicion of carcinoma. (SIGN 29)
C - Magnetic resonance imaging (MRI) should be considered in specific clinical situations where other imaging modalities are not reliable, or have been inconclusive, and where there are indications that magnetic resonance imaging is useful.
Surgery
Conservative Surgery Versus Mastectomy
A - All women with early stage invasive breast cancer who are candidates for breast conserving surgery should be offered the choice of breast conserving surgery (excision of tumour with clear margins) or modified radical mastectomy.
A - The choice of surgery must be tailored to the individual patient, who should be fully informed of the options and who should be aware that breast irradiation is required following conservation and that further surgery may be required if the margins are positive.
C - Breast conserving surgery is contraindicated if:
- The ratio of the size of the tumour to the size of the breast would not result in acceptable cosmesis.
- There is multifocal disease or extensive malignant microcalcification on mammogram.
- There is a contraindication to local radiotherapy (e.g., previous radiotherapy at this site, connective tissue disease, severe heart and lung disease, pregnancy).
C - Central situation of the tumour is not a contraindication to conservation, although it may require excision of the nipple and areola, which may compromise cosmesis.
Breast Reconstruction after Mastectomy
C - The possibility of breast reconstruction should be discussed with all patients prior to mastectomy. (SIGN 29)
Surgical Management of the Axilla
A - Axillary surgery should be performed in all patients with invasive breast cancer.
Management of Ductal Carcinoma In Situ
Choice of Mastectomy or Breast Conserving Surgery
B - Women with ductal carcinoma in situ who are candidates for breast surgery should be offered the choice of lumpectomy or mastectomy.
Irradiation Following Breast Conserving Surgery
A - Women who have undergone breast conserving surgery should be offered postoperative breast irradiation.
Radiotherapy
Adjuvant Radiotherapy
A - Radiotherapy should be given following mastectomy or breast conserving surgery to reduce local recurrence where the benefit to the individual is likely to outweigh risks of radiation related morbidity.
Selecting the Appropriate Site
Chest Wall and Supraclavicular Fossa Radiotherapy
D - The supraclavicular field should be irradiated in all patients with four or more positive axillary nodes.
Systemic Therapy
Adjuvant Chemotherapy
A - All women under the age of 70 years, with early breast cancer should be considered for adjuvant chemotherapy.
C - Women with oestrogen receptor-positive tumours who receive chemotherapy should be considered for additional endocrine therapy, especially if they are under 35 years.
Neoadjuvant Chemotherapy
A - Neoadjuvant chemotherapy should be considered for women with large cancers as it improves the rate of breast conservation and is not detrimental to long term outcome.
Anthracycline and Taxane Therapy
Advanced Disease
Epirubicin
A - Anthracyclines should be prescribed in preference to non-anthracycline regimens in the adjuvant setting, as they offer additional benefits. Epirubicin may be preferred as it causes less cardiac adverse effects.
Taxanes
A - Taxanes should be considered in patients with advanced disease.
Biological Therapies
Trastuzumab Monotherapy
C - Trastuzumab should be reserved for those patients whose tumours have human epidermal growth factor receptor 2 (HER2) overexpression.
Trastuzumab Combination Therapy
A - Combination therapy of trastuzumab with a taxane is recommended in women with metastatic breast cancer.
Vinorelbine and Capecitabine Therapy
Capecitabine
A - Either capecitabine or vinorelbine should be considered for patients with advanced breast cancer.
Role of Bisphosphonates
Bisphosphonates and Metastatic Disease
A - Bisphosphonates should be routinely used in combination with other systemic therapy in patients with metastatic breast cancer with symptomatic bone metastases. The choice of agent for an individual patient depends on individual circumstances.
Endocrine Therapy
Premenopausal Women
A - Premenopausal women whose tumours are not shown to have absent oestrogen or progesterone receptors should be considered for adjuvant endocrine therapy.
A - In premenopausal women with advanced disease, the combination of tamoxifen plus ovarian ablation should be offered before tamoxifen therapy alone.
Postmenopausal Women
Advanced Disease
A - In postmenopausal women with breast cancer tamoxifen remains the treatment of choice as initial therapy in the adjuvant setting. If there are relative contraindications to its use (high risk of thromboembolism or endometrial abnormalities) or intolerance, an aromatase inhibitor can be used in its place.
A - Postmenopausal patients should be considered for a switch to an aromatase inhibitor after either two to three years or after five years of tamoxifen therapy.
A - In postmenopausal women with advanced disease, third generation aromatase inhibitors should be considered before either tamoxifen or megestrol acetate.
Timing of Surgery and Chemotherapy
C - All treatments for patients with early breast cancer should be started as soon as is practical. Young women with oestrogen receptor negative tumours may benefit particularly from early initiation of chemotherapy following surgery.
Management of Menopausal Symptoms
B - Megestrol acetate or depot intramuscular medroxyprogesterone acetate may be considered to control the severity of hot flushes in women with breast cancer.
Psychological Care
The Role of the Breast Care Nurse
C - All women with a potential or known diagnosis of breast cancer should have access to a breast care nurse specialist for information and support at every stage of diagnosis and treatment.
Education
D - Breast care nurse specialists should have appropriate education and experience.
Identifying Distress
B - The measurement of the presence of psychological symptoms in women with breast cancer should be tailored to the individual circumstances of the patient (e.g., presence of high level of distress or risk factors for problems).
B - Routinely administered questionnaires are not recommended for the detection of clinically significant psychological symptoms in women with breast cancer who do not have specific risk factors for severe anxiety or distress.
Psychological Support for Women with Breast Cancer and Their Families
Group Based Psychological Interventions
A - Group psychological interventions should be available to women with breast cancer who feel it would suit their needs.
A - Supportive expressive therapy is recommended for patients with advanced cancer and cognitive behavioural therapy for patients with localised, locoregional, or advanced disease.
Individual Interventions
A - Cognitive behavioural therapy (in group or individual format according to preference and availability) should be offered to selected patients with anxiety and depressive disorders.
A - Computer and telephone-based interventions should not routinely be offered to patients.
Communication Methods
A - Women with breast cancer should be offered audiotapes or follow up summary letters of important consultations.
A - Clinical encounters with women with breast cancer should facilitate patient choice about treatment decisions (assuming patients wish to participate in the decision making process).
A - Written agendas, prompt sheets, and decisions aids should be used to improve communication with women with breast cancer.
A - Clinicians should be encouraged to attend validated training in communication skills.
Follow-up
Improving Outcomes
Patients without Recurrence
Detection of Recurrence in the Treated Breast and New Primary in the Contralateral Breast
C - Mammography should be used to detect recurrence in patients who have undergone previous treatment for breast cancer.
Identifying Patients with Metastatic Disease
Detection of Distant Metastases
B - Routine diagnostic tests to screen for distant metastases in asymptomatic women should not be performed.
Specialist Palliative Care
B - Patients with breast cancer should have access to input from a specialist palliative care team.
Definitions
Grades of Recommendation
Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.
A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D: Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group
SIGN 29: Verbatim extract from the previous version of the guideline, SIGN 29, published in 1998. This material covers areas that were not updated in the current version of the guideline. It should be remembered that these older recommendations have not been developed with the rigour of current SIGN methodology and the evidence on which they are based may have been superseded. The grading system of these recommendations does not map consistently to the current SIGN grading system.
Levels of Evidence
1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3: Non-analytic studies (e.g. case reports, case series)
4: Expert opinion
