Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Sponsor
Shandong Cancer Hospital and Institute
Study ID
NCT02544243
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
  • Gemcitabine — DRUG
  • Cisplatin — DRUG

Study Details

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

Key Dates

Start date
Sep 30, 2015
Status verified
Sep 2015
Primary completion
Aug 31, 2017

Study Design

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

Arms

  • Experimental: A
    Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
  • Experimental: B
    Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks

Primary Outcome Measure

Progression Free Survival [ Time Frame: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months ]

Central Contacts

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