Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00431106
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
  • Capecitabine — DRUG
    Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
  • Vinorelbine — DRUG
    Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles

Study Details

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Key Dates

Start date
Apr 30, 2002
Status verified
Sep 2009
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

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

Arms

  • Active Comparator: 1
    Vinorelbine/Gemcitabine (VG)
  • Active Comparator: 2
    Capecitabine (Cap)

Primary Outcome Measure

Time to tumor progression between the two treatment arms [ Time Frame: 1 year ]

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