Ensayos clínicos

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