Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer

Sponsor
Pierre Fabre Medicament
Study ID
NCT03887130
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oral vinorelbine — DRUG
    Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
  • Gemcitabine 1250 mg/m² — DRUG
    Gemcitabine 1250 mg/m² on day 1 \& day 8
  • Gemcitabine 1000 mg/m² — DRUG
    Gemcitabine: 1000 mg/m² on day 1 \& 8
  • Paclitaxel — DRUG
    Paclitaxel 175 mg/m² on day 1
  • Docetaxel — DRUG
    Docetaxel 75 mg/m² on day 1

Study Details

The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

Key Dates

Start date
Mar 27, 2007
Status verified
Feb 2024
Primary completion
Apr 18, 2013
Completion
Apr 18, 2013

Study Design

Enrollment
152 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vinorelbine-Capecitabine (arm A)
    oral vinorelbine (OV) with capecitabine (CAP)
  • Active Comparator: Gemcitabine-Paclitaxel (arm B)
    gemcitabine (GEM) in combination with paclitaxel (PAC)
  • Active Comparator: Gemcitabine-Docetaxel (arm C)
    gemcitabine (GEM) in combination with docetaxel (DOC)

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: From Baseline to disease progression or death, up to 6 years ]

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