Masuda 2012.

Methods	Accrual: September 2009 to September 2011 Multicentre, phase II randomised controlled trial conducted in Japan Neoadjuvant study
Participants	Median age 54 years (range 33–70 years) Median tumour size 35 mm (range 12–80 mm) 40.8% node‐positive 60.2% ER‐positive 100% HER2‐positive breast cancer
Interventions	Arm 1: docetaxel (75 mg/m²), cyclophosphamide (600 mg/m²), trastuzumab (6 mg/kg, loading by 8 mg) for 4 cycles, followed by 5‐fluorouracil (500 mg/m²), epirubicin (100 mg/m²), cyclophosphamide (500 mg/m²) for 4 cycles Arm 2: 5 fluorouracil (500 mg/m²), epirubicin (100 mg/m²), cyclophosphamide (500 mg/m²) for 4 cycles, followed by docetaxel (75 mg/m²), cyclophosphamide (600 mg/m²), trastuzumab (6 mg/kg, loading by 8 mg) for 4 cycles Arm 3: docetaxel (75 mg/m²), cyclophosphamide (600 mg/m²), trastuzumab (6 mg/kg, loading by 8 mg) for 6 cycles An interim analysis of pCR noted that anthracycline‐containing regimens did not exceed benefit from the current standard regimen and, therefore, study limited allocation only to arm 3. Data for arm 1 and arm 2 only are relevant for this Cochrane review topic
Outcomes	Primary outcome pCR Secondary outcomes Overall response rate Safety (e.g. cardiac toxicity)
Notes	Clinical trial registry record: UMIN000002365 Last follow‐up date: 1 August 2014 Clinical trials registry record stated that results were partially published at San Antonio Breast Cancer Symposium 2012. Research contact person: Norikazu Masuda, nmasuda@alpha.ocn.ne.jp; public contact person: Katsumasa Kuroi, office@jbcrg.jp Authors contacted in May 2018 for data relating to comparison of arm 1 and arm 2 (as data were not reported in San Antonio Breast Cancer Symposium 2012 abstract); no reply. Funding considerations: Japan Breast Cancer Research Group; self‐funded