EORTC 10041/BIG 3‐04 MINDACT.

Methods	Randomised controlled trial Multi‐centre, international Randomisation method not specified
Participants	Women, premenopausal and postmenopausal Operable breast cancer Node‐negative or fewer than 3 positive lymph nodes Exclusion of metastatic disease For inclusion in chemotherapy randomisation, 1 of the following criteria must be met: (a) high risk of recurrence according to both clinical‐pathological criteria and 70‐gene signature, (b) high risk of recurrence according to clinical‐pathological criteria and low risk of recurrence according to 70‐gene signature and randomised to use the clinical‐pathological criteria for chemotherapy decision, or (c) low risk of recurrence according to clinical‐pathological criteria and high risk of recurrence according to 70‐gene signature and randomised to use the 70‐gene signature for chemotherapy decision
Interventions	ARM 1 (anthracycline‐based): patients can receive 1 of the following regimens: FEC 100: on day 1 × 6 21‐day cycles Canadian CEF: cyclophosphamide on days 1 to 14 and epirubicin and fluorouracil on days 1 and 8, × 6 28‐day cycles CAF: cyclophosphamide, doxorubicin, and fluorouracil on day 1 × 6 28‐day cycles FAC: cyclophosphamide, doxorubicin, and fluorouracil on days 1 and 8 × 6 21‐day cycles E‐CMF: epirubicin on day 1, × 4 21‐day cycles ARM 2 (docetaxel and capecitabine): Docetaxel on day 1 and oral capecitabine twice daily on days 1 to 14 × 6 21‐day cycles Endocrine therapy (for all postmenopausal and some premenopausal patients who have endocrine‐responsive tumours)
Outcomes	Primary endpoints: Distant metastasis‐free survival at 5 years Disease‐free survival (DFS) Secondary endpoints: Proportion of patients treated with chemotherapy based on clinical prognosis compared to 70‐gene signature prognosis Overall survival at 5 years DFS at 5 years Safety (early and late)
Notes	Awaiting full‐text publication following conference proceedings abstract