Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed breast cancer
• •* Metastatic (stage IV) disease
• •Measurable disease by RECIST criteria
• •* Irradiated lesions are not considered measurable disease
• •Central nervous system (CNS) metastases allowed if disease is stable (no evidence of progression) ≥ 3 months after local therapy
• •No lesions identifiable only by positron emission tomography (PET) scan
• •HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by Fluorescence In Situ Hybridization (FISH)
• •* HER2 2+ by IHC allowed
• •Hormone receptor status:
• •* Estrogen receptor-negative and progesterone receptor-negative tumor
• •At least 18 years of age
• •Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria
• •No more than three prior chemotherapy regimens either in the adjuvant or metastatic setting.
• •Histologically documented (either primary or metastatic site) breast cancer that is estrogen receptor- (ER-) negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion. HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory test should be performed when possible, however may participate if fulfill other criteria.
• •Completion of prior chemotherapy at least 3 weeks prior to study entry.
• •Patients may have received therapy (ies) in the adjuvant or metastatic setting, however must have discontinued prior to entry. Patients may receive concurrent bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for progression or response.
• •Radiation therapy must be completed at least 2 weeks prior to study entry, and radiated lesions may not serve as measurable disease.
• •Patients may have CNS metastases if stable (no evidence of progression) \> 3 months after local therapy.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and life expectancy of at least 6 months.
• •Adequate organ function defined as:absolute neutrophil count (ANC) \> 1500/mm3, plts \> 100,000/mm3, creatinine clearance \>50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) (or ≤5 x ULN in case of liver metastases); total bilirubin ≤1.5 mg/dL.
• •Tissue block available for EGFR studies is recommended, although will not exclude patients from participating.
• •Pregnant or lactating women will be excluded. Women of child bearing potential must have documented negative pregnancy test within two weeks of study entry and agree to acceptable birth control during the duration of the study therapy.
• •Signed written informed consent.