Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
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|ClinicalTrials.gov Identifier: NCT00019812|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 23, 2012
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: trastuzumab Drug: paclitaxel||Phase 2|
- Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
- Provide access to trastuzumab and paclitaxel for these patients.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Official Title:||Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer|
|Study Start Date :||August 1999|
|Actual Study Completion Date :||February 2004|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019812
|United States, Florida|
|Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, West Virginia|
|Mary Babb Randolph Center|
|Morgantown, West Virginia, United States, 26506-9162|
|Principal Investigator:||Susan E. Bates, MD||National Cancer Institute (NCI)|