OPTIMA BCT 2202

1. Female or male, age >= 40
2. Excised invasive breast cancer with local treatment either completed or planned according to trial guidelines.
3. ER positive (Allred score >=3 or H-score >=10 or >1% of tumour cells stained positive) as determined by the referring site (in a laboratory meeting NEQAS standards).
4. HER2 negative (IHC 0-1+, or ISH negative/non-amplified (ratio of HER2/chromosome 17 <2.00 and copy number <6)) as determined by the referring site (in a laboratory meeting NEQAS standards).
5. Axillary lymph node status:
5.1. 1-9 involved (macrometastases i.e. >2mm) OR
5.2. Node negative AND tumour size >= 30mm.
Nodes containing micrometastases (i.e. >0.2-2mm) or isolated tumour cell clusters (ITC) only (i.e. <=0.2mm) will be considered to be uninvolved.
6. Considered appropriate for adjuvant chemotherapy by treating physician.
7. Patient must be fit to receive chemotherapy and other trial-specified treatments with no concomitant medical, psychiatric or social problems that might interfere with informed consent, treatment compliance or follow up.
8. Bilateral cancers are permitted provided at least one tumour fulfils the entry criteria and none meet any of the exclusion criteria.
9. Multiple ipsilateral cancers are permitted provided at least one tumour fulfils the entry criteria and none meet any of the exclusion criteria.
10. Written informed consent for the study.

1. >=10 involved axillary nodes (as defined in the inclusion criteria) or involved internal mammary node.
2. ER negative OR HER2 positive/amplified (as determined by the referring site).
3. Metastatic disease.
4. Previous diagnosis of malignancy unless:
4.1. Managed by surgical treatment only and disease free for 10 years
4.2. Previous basal cell carcinoma of skin, cervical intraepithelial neoplasia or ductal carcinoma in situ (DCIS) of the breast treated with surgery only or previous diagnosis of lobular carcinoma in situ (LCIS).
5. The use of oestrogen replacement therapy (HRT) at the time of surgery. Patients who are taking HRT at the time of diagnosis are eligible provided the HRT is stopped before surgery.
6. Pre-surgical chemotherapy, endocrine therapy or radiotherapy for breast cancer. Treatment with endocrine agents known to be active in breast cancer including ovarian suppression is permitted provided this was completed >1 year prior to study entry.
7. Commencement of adjuvant treatment prior to trial entry. Short-term endocrine therapy initiated because of, for instance, prolonged recovery from surgery is permitted but must be discontinued at trial entry.
8. Trial entry more than 8 weeks after completion of breast cancer surgery.
9. Planned further surgery for breast cancer, including axillary surgery, to take place after randomisation, except either re-excision or completion mastectomy for close or positive/involved margins which may be undertaken following completion of chemotherapy.
10. Patients with more than two involved axillary nodes (as defined in the inclusion criteria) identified by sentinel node biopsy or by axillary sampling where further axillary surgery is not planned.

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