Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer

Overview

About this study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic adenocarcinoma of the breast
Strong overexpression of HER-2 by immunohistochemistry (3+)
- 0-2+ tumors allowed if demonstrate amplification by FISH
Bidimensionally measurable disease
Brain metastasis must not represent sole site of disease
No untreated brain metastasis receiving radiotherapy
Previously treated brain metastases in continued response to radiotherapy and/or surgery for at least 2 months allowed
Hormone receptor status:
- Positive or negative

PATIENT CHARACTERISTICS:

Age: 18 and over
Sex: Female
Menopausal status: Not specified
Performance status: ECOG 0-2
Life expectancy: At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal: Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No myocardial infarction within the past 6 months
- No congestive heart failure or unstable angina
- No clinically significant pericardial effusion or arrhythmia
Other:
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No active uncontrolled infection
- No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy: No concurrent filgrastim (G-CSF)
Chemotherapy:
- Prior adjuvant chemotherapy allowed
- Prior taxane therapy allowed
- No prior cisplatin or carboplatin
- No prior chemotherapy for metastatic disease
Endocrine therapy: Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of marrow
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
Other: At least 7 days since prior parenteral antibiotics

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