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
Secondary
|
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 |