Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy
- Sponsor
- Zhiyong Yu
- Study ID
- NCT03703427
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Pathologic Residual Cancer Cells
Eligibility Criteria
- Sex
- FEMALE
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Capecitabine, Oral, 500 Mg — DRUG1250mg/m2，d1-d14，q3w
- Vinorelbine Tartrate Oral — DRUG60mg/m2，d1；d8；q3w
Study Details
This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.
Key Dates
- Start date
- Nov 30, 2018
- Status verified
- Oct 2018
- Primary completion
- Nov 30, 2023
- Completion
- Nov 30, 2025
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Capecitabine
- Experimental: Vinorelbine
Primary Outcome Measure
disease free survival(DFS) [ Time Frame: 5 years ]