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. 2023 Sep 8;2023(9):CD014805. doi: 10.1002/14651858.CD014805.pub2

NCT02455141.

Study name Adjuvant treatment of EC followed by taxane ± carboplatin in triple‐negative breast cancer
Methods Accrual: recruiting
Accrual target: 970
Multicentre, phase 3 RCT
Trial is being conducted in China
Blinding: open‐label study
Participants Histologically confirmed triple‐negative breast cancer, with tumour removal by either modified radical mastectomy or local excision plus axillary lymph node dissection
Adjuvant or neoadjuvant: adjuvant
Interventions Arm 1: intervention: epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 day 1, every 3 weeks for 4 cycles followed by paclitaxel 80 mg/m2 days 1, 8, 15 every 4 weeks for 4 cycles and carboplatin AUC2 for 4 cycles or, docetaxel 75 mg/m2 day 1 every 3 weeks for 4 cycles and carboplatin AUC5–6 day 1 every 3 weeks for 4 cycles

Arm 2: comparator: epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 day 1, every 3 weeks for 4 cycles followed by paclitaxel 80 mg/m2 days 1 every 12 weeks or docetaxel 80–100 mg/m2 every 3 weeks for 4 cycles
Outcomes Primary
  • Disease‐free survival


Secondary
  • Overall survival

  • Incidence of neutropenia fever

  • Incidence of grade III/IV adverse effects

Starting date Actual start date: July 2015
Estimated completion date: December 2023
Contact information Contact: Xiaosong Chen (chenxiaosong0156@hotmail.com)
Notes Trial registration link: clinicaltrials.gov/ct2/show/NCT02455141
Trial sponsor: Shanghai Jiao Tong University School of Medicine
Funding considerations: not specified in trial record