NCT02641847.
Study name | TA(E)C‐GP versus A(E)C‐T for the high risk TNBC patients and validation of the mRNA‐lncRNA signature |
Methods | Accrual: unknown Accrual target: 503 Single‐centre, phase 2/3 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 ('high risk group A' in trial record): docetaxel 75 mg/m2 and doxorubicin 50 mg/m2 or epirubicin 75 mg/m2 on day 1 for 4 cycles and cyclophosphamide 500 mg/m2 on day 1, gemcitabine 1250 mg/m2 on days 1 and 8, and cisplatin 75 mg/m2 on day 1 every 21 days for 4 cycles Arm 2: comparator 1 and 2 ('high risk group B' and 'low risk group C' in trial record): doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 on day 1 and cyclophosphamide 600 mg/m2 on day 1 for 4 cycles and docetaxel 100 mg/m2 on day 1 for 4 cycles |
Outcomes | Primary
Secondary
|
Starting date | Planned start date: July 2015 Estimated completion date: June 2021 |
Contact information | Contact: Zhi‐min Shao (zhimingshao@yahoo.com) |
Notes | Trial registration link: clinicaltrials.gov/ct2/show/NCT02641847 Trial sponsor: Fudan University Funding considerations: not specified in trial record |