Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
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.
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.
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