Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00041067
Brief Summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the 1-year survival of women with HER2-positive stage IV breast cancer treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim (G-CSF) support.
* Determine the response rate (complete and partial, confirmed and unconfirmed) in the subset of patients with measurable disease treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Obtain tissue blocks for the determination of predictors of response (e.g., beta-tubulin mutations) to microtubule interacting agents in this patient population and for other future studies.
OUTLINE: This is a pilot, multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy with G-CSF support.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5 months.
Study:
NCT00041067
Study Brief:
Protocol Section:
NCT00041067