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

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
  • Recurrence‐free survival


Secondary
  • Treatment‐related adverse events

  • Disease‐free survival

  • Overall survival

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