Optima: This study is comparing the management of patients with breast cancer using test-directed assignment to chemotherapy with standard management (chemotherapy)Optimal personalised treatment of early breast cancer using multiparameter analysis

Exclusion

Current exclusion criteria as of 29/09/2015:
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.