Phase II Study of Gemcitabine/Vinorelbine vs Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer

Sponsor
National Cancer Center, Korea
Study ID
NCT00532623
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Gemcitabine plus Vinorelbine — DRUG
    Gemcitabine, 1,000mg/m2 and Vinorelbine, 25mg/m2, on day 1 and day 8, every 3 week cycles
  • Sequential — DRUG
    Gemcitabine monotherapy followed by Vinorelbine monotherapy: -Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.

Study Details

To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage IV and recurrent breast cancer.

Key Dates

Start date
May 31, 2004
Status verified
Sep 2007
Primary completion
Sep 30, 2006
Completion
Oct 31, 2006

Study Design

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

Arms

  • Active Comparator: Combination
  • Active Comparator: Seqeuntial
    Gemcitabine monotherapy followed by Vinorelbine monotherapy: -Gemcitabine: 1,200 mg/m2, intravenously, on day 1 and day 8 in 3 week cycles. Vinorelbine: 30 mg/ m2, intravenously, on day 1 and day 8 in 3 week cycles.

Primary Outcome Measure

overall response rate [ Time Frame: 3 years ]

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