A Trial of Gemcitabine Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00192062
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase II study of gemcitabine- Vinorelbine combination in a 3-weekly schedule as first line chemotherapy in patients with metastatic breast cancer. Eighty patients with measurable disease will be enrolled in the study. Gemcitabine will be used at 1000 mg/m2, vinorelbine at 25mg/m2. Every cycle, vinorelbine will be administered before gemcitabine. After the initial dose, modifications of Gemcitabine and vinorelbine doses are allowed based on patient toxicity Study therapy may continue until: * There is evidence of progressive disease * The patient experiences unacceptable toxicity. * The investigator decides that the patient should be discontinued * The patient requests discontinuation * The patient has received 6 cycles of the regimen(if the physician decides to continue after 6 cycles-this will be done after consultation with the sponsor) * Discontinuation from study therapy is indicated according to the protocol It's the investigator's responsibility to strictly stick to the protocol procedures. It needs to be discussed with Lilly medical designee in advance when any special situation occurs which has not been defined in protocol. After patients discontinue from study therapy, they proceed to the post-study follow up phase of the study. Assessments to take place during this phase are outlined in the protocol.

Key Dates

Start date
Jul 31, 2004
Status verified
Aug 2007
Completion
Jun 30, 2007

Study Design

Enrollment
80 participants
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To evaluate the response rate of Gemcitabine-vinorelbine when used in a 3-weekly as first line chemotherapy in patients with metastatic breast cancer.

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