Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT00146549
- Phase
- PHASE3
- Status
- Completed
Conditions
- Breast Cancer
- Stage IV Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab — DRUG
- Vinorelbine — DRUG
- Paclitaxel — DRUG
- Docetaxel — DRUG
Study Details
The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.
Key Dates
- Start date
- Aug 31, 2001
- Status verified
- Oct 2009
- Primary completion
- Aug 31, 2007
- Completion
- Dec 31, 2007
Study Design
- Enrollment
- 250 participants
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
To compare the overall response rate for patients receiving trastuzumab in combination with either vinorelbine or taxane-based chemotherapy.
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
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