Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, 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. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.
Drug: vinorelbine tartrate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer|
- Overall response rate as measured by RECIST criteria [ Designated as safety issue: No ]
- Time to progression as measured by RECIST criteria [ Designated as safety issue: No ]
- Duration of response as measured by RECIST criteria [ Designated as safety issue: No ]
- Overall survival as assessed by time [ Designated as safety issue: No ]
- Safety as assessed by CTC3 [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- Determine the overall response rate in patients with HER2/neu-overexpressing metastatic breast cancer treated with first- or second-line therapy comprising capecitabine, vinorelbine, and trastuzumab (Herceptin^®).
- Determine the time to disease progression, duration of response, and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14, vinorelbine IV over 6-10 minutes on days 1 and 8, and trastuzumab (Herceptin^®) IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 5-47 patients will be accrued for this study within 23 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093808
Show 147 Study Locations
|Study Chair:||Winston Tan, MD, FACP||Mayo Clinic|
|Investigator:||Muhammad Salim, MD||Saskatchewan Cancer Agency|
|Investigator:||Edith A. Perez, MD||Mayo Clinic|