UMIN000003283.

Trial name or title	A randomized study of docetaxel + cyclophosphamide (TC), 5‐fluorouracil + epirubicin + cyclophosphamide (FEC)‐TC and TC‐FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer JBCRG‐09
Methods	Accrual: 1 September 2009 to undisclosed date Accrual target: 195 Phase II cluster randomised controlled trial conducted in Japan Multicentre Neoadjuvant study Last follow‐up date: 31 May 2017
Participants	Hormone receptor‐positive and HER2‐negative primary breast cancer Primary breast cancer defined as T1c‐3 N0‐1, m0 and tumour size ≤ 7 cm
Interventions	Arm 1: docetaxel (75 mg/m²) for 1 hour day 1, cyclophosphamide (600 mg/m²), 15‐30 minutes day 1 for 3 cycles followed 5‐fluorouracil (500 mg/m²) day 1, epirubicin (100 mg/m²) day 1 and cyclophosphamide (500 mg/m²) day 1 for 3 cycles Arm 2: 5‐fluorouracil (500 mg/m²) day 1, epirubicin (100 mg/m²) day 1 and cyclophosphamide (500 mg/m²) day 1 for 3 cycles followed by docetaxel (75 mg/m²) for 1 hour day 1, cyclophosphamide (600 mg/m²), 15‐30 minutes day 1 for 3 cycles Arm 3: docetaxel (75 mg/m²) for 1 hour day 1, cyclophosphamide (600 mg/m²), 15‐30 minutes day 1 for 6 cycles
Outcomes	Primary outcome Pathological complete response rate Secondary outcomes Safety Overall response rate Disease‐free survival Overall survival Clinical response evaluation using various diagnostic imaging techniques
Starting date	Start date: 1 September 2009 Estimated completion date: 31 May 2017 (last follow‐up date recorded)
Contact information	Research contact person: Norikazu Masuda, nmasuda@alpha.ocn.ne.jp; public contact person: Katsumasa Kuroi, office@jbcrg.jp
Notes	Funding considerations: Japan Breast Cancer Research Group (JBCRG); self‐funded