Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Sponsor
Fudan University
Study ID
NCT02607215
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    25 mg/m2, D1, D8
  • DDP — DRUG
    75 mg/m2, D1

Study Details

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Key Dates

Start date
Nov 30, 2015
Status verified
Apr 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vinorelbine Plus DDP
    Vinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days
  • Active Comparator: Vinorelbine
    Vinorelbine:30 mg/m2, D1, D8 every 21 days

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 6 weeks ]

Central Contacts

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