Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Study of Trastuzumab (Herceptin) and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic breast cancer with HER2
overexpression
- Radiographically or physically measurable disease that can be biopsied safely under
local anesthesia
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- AST and ALT no greater than 5 times ULN
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 2 weeks since prior hormonal therapy
- No concurrent hormone receptor therapy (e.g., tamoxifen or armidex)
Radiotherapy:
- Localized palliative external beam radiotherapy allowed
Surgery:
- Not specified
Other:
- Concurrent bisphosphonates allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Susan E. Bates, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
990121
NCT ID:
NCT00019812
Start Date:
August 1999
Completion Date:
February 2004
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
| Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Mary Babb Randolph Center | Morgantown, West Virginia 26506-9162 |
