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

NCT02879513.

Study name Trial of adjuvant chemotherapy in breast cancer patients with pathological partial response and complete response to neoadjuvant chemotherapy
Methods Accrual: recruiting
Accrual target: 290
Single or multicentre, phase 3 RCT
Trial is being conducted in China
Blinding: open‐label study
Participants People with locally advanced breast cancer and had weekly paclitaxel and cisplatin as neoadjuvant chemotherapy
Adjuvant or neoadjuvant: adjuvant
Interventions Arm 1: intervention 1 and 2 ('continue neoadjuvant regimen' and 'pathological complete response group with chemotherapy in trial record): paclitaxel 80 mg/m2 on days 1 and 8 for 16 weeks, followed by cisplatin 25 mg/m2 weekly on days 1, 8 and 15, every 4 weeks for 4 cycles

Arm 2: comparator: epirubicin 75 mg/m2 on day 1 every 3 weeks for 4 cycles, cyclophosphamide 500 mg/m2 on day 1 every 3 weeks and 5‐fluorouracil 500 mg/m2 on day 1 every 3 weeks
Outcomes Primary
  • Disease‐free survival


Second
  • Overall survival

  • Treatment‐related adverse events

  • Regional recurrence‐free survival

  • Local recurrence‐free survival

  • Distant disease‐free survival

Starting date Planned start date: January 2014
Estimated completion date: December 2022
Contact information Contact: Jinsong Lu (lujjss@163.com)
Notes Trial registration link: clinicaltrials.gov/ct2/show/NCT02879513
Trial sponsor: RenJi Hospital
Funding considerations: not specified in trial record