Cetuximab With or Without Carboplatin in Treating Women With Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

  • Metastatic (stage IV) disease

• Measurable disease by RECIST criteria

  • Irradiated lesions are not considered measurable disease
• CNS metastases allowed if disease is stable (no evidence of progression) ≥ 3 months after local therapy
• No lesions identifiable only by PET scan

• HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by FISH

  • HER2 2+ by IHC allowed

• Hormone receptor status:

  • Estrogen receptor-negative and progesterone receptor-negative tumor

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 6 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine clearance ≥ 50 mL/min
• ALT and AST ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in case of liver metastases)
• Bilirubin ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

  • Uncontrolled hypertension
  • Unstable angina
  • Recent myocardial infarction (within the past 6 months)
  • Uncontrolled congestive heart failure
  • Cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction < 45%
• No history of severe infusion reaction to monoclonal antibody treatment
• No uncontrolled infection
• No major medical condition (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction) that may affect study participation
• No other significant comorbid condition that may compromise effective and safe participation in the study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy
• At least 2 weeks since prior radiation therapy

• No more than 3 prior chemotherapy regimens either in the adjuvant or metastatic setting

  • Sequential regimens (e.g., anthracycline-paclitaxel) are considered 1 regimen
• No prior therapy that specifically and directly targets the EGFR pathway with therapeutic intent
• No prior platinum agent for metastatic disease
• Prior platinum agents in the adjuvant setting allowed provided there was a disease-free interval that lasted for ≥ 12 months prior to relapse

• Concurrent bisphosphonates allowed

  • Bone lesions may not be used to measure progression or response