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
Second
|
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 |