NCT04296175.

Study name	Carboplatin intensified chemotherapy for triple negative breast cancer (CITRINE)
Methods	Accrual: recruiting Accrual target: 808 Single‐centre, phase 3 RCT Trial is being conducted in China Blinding: open‐label study
Participants	People with high‐risk, triple‐negative breast cancer. High risk defined as positive lymph nodes or negative lymph nodes but ki‐67 is not less than 50%
Interventions	Arm 1: intervention: epirubicin 90 mg/m2 on day 1 and cyclophosphamide 600 mg/m2 on day 1 every 2 weeks followed by paclitaxel 80 mg/m2 and carboplatin AUC2 on days 1, 8 and 15 every 4 weeks Arm 2: comparator: epirubicin 90 mg/m2 on day 1 and cyclophosphamide 600 mg/m2 on day 1 every 2 or 3 weeks followed by paclitaxel 80 mg/m2 on days 1, 8 and 15 every 3 weeks
Outcomes	Primary Disease‐free survival Secondary Overall survival at 3 and 5 years Distant disease‐free survival at 3 or 5 years Recurrence‐free survival at 3 and 5 years
Starting date	Planned start date: 18 September 2018 Estimated completion date: June 2025
Contact information	Contact: Zhimin Shao (zhimingshao@yahoo.com)
Notes	Trial registration link: clinicaltrials.gov/ct2/show/NCT04296175 Trial sponsor: Fudan University Funding considerations: not specified in trial record