Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
- Sponsor
- Fudan University
- Study ID
- NCT03254654
- Phase
- PHASE2
- Status
- Completed
Conditions
- Advanced Triple-Negative Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Vinorelbine — DRUGExperimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
- Apatinib — DRUG250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
Study Details
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
Key Dates
- Start date
- Aug 16, 2017
- Status verified
- Apr 2022
- Primary completion
- Aug 1, 2021
- Completion
- Aug 1, 2021
Study Design
- Enrollment
- 66 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Vinorelbine Plus ApatinibVinorelbine: 20 mg/m2, D6, D13, D20 Apatinib: 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
- Active Comparator: VinorelbineVinorelbine: 25 mg/m2, D1, D8, D15
Primary Outcome Measure
PFS [ Time Frame: 6 weeks ]