Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Institutes of Health Clinical Center (CC)
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
