NCT03201861.

Study name	Addition of cisplatin to adjuvant chemotherapy for early stage breast cancer in high‐risk women
Methods	Accrual: recruiting Accrual target: 762 Single‐centre, phase 3 RCT Trial is being conducted in China Blinding: open‐label study
Participants	People with triple‐negative breast cancer confirmed by pathology Adjuvant or neoadjuvant: adjuvant
Interventions	Arm 1: intervention: paclitaxel 80 mg/m2 on days 1 and 8 for 12 weeks and cisplatin 25 mg/m2 on days 1, 8 and 15 every 4 weeks for 3 cycles followed by epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 day 1 for 4 cycles Arm 2: comparator: epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 on day 1 every 3 weeks for 4 cycles followed by paclitaxel 80 mg/m2 for 12 weeks or docetaxel 75 mg/m2 on day 1 every 21 days for 4 cycles
Outcomes	Primary Disease‐free survival Secondary Overall survival Treatment‐related adverse events
Starting date	Planned start date: 27 July 2017 Estimated completion date: 31 December 2022
Contact information	Contact: Yueyao Du (jessicayy8629@126.com)
Notes	Trial registration link: clinicaltrials.gov/ct2/show/NCT03201861 Trial sponsor: RenJi Hospital Funding considerations: not specified in trial record