Phase II Study of Chemotherapy with or without Erbitux for Metastatic Breast Cancer Patients

Inclusion Criteria

• Must have confirmed breast cancer that is either HER2 positive or negative.
• Must have Stage IV metastatic breast cancer.
• Must have had prior Herceptin therapy if the cancer is HER2 positive.
• Must have measurable metastatic breast cancer according to specific criteria.
• Can have had up to one prior chemotherapy regimen for metastatic disease.
• Must not have had prior treatment with irinotecan, carboplatin, or cisplatin.
• Must have an ECOG performance status of 0 to 2.
• Must be over 18 years old.
• Must meet specific laboratory test requirements.
• Any prior radiation therapy must have been completed more than 2 weeks before starting the study treatment.
• Female patients of childbearing potential must have a negative pregnancy test before starting the study.
• Must agree to use effective birth control during the study and for 6 months after.
• Must provide informed consent and authorization for the study.
• Must have breast cancer tissue samples available for analysis.

Exclusion Criteria

• Cannot have Stage I-III breast cancer or non-measurable metastatic breast cancer.
• Cannot have had prior treatment with irinotecan, carboplatin, or cisplatin.
• Cannot be receiving any other chemotherapy or investigational drugs not included in the study.
• Cannot have had prior treatment targeting the EGFR pathway, except for Herceptin in HER2 positive patients.
• Cannot have had severe reactions to monoclonal antibodies.
• Cannot have received organ transplants other than corneal, bone, or skin.
• Cannot have uncontrolled heart disease or recent heart attack.
• Cannot have ongoing severe nerve damage.
• Cannot have untreated or symptomatic brain metastases.
• Cannot have significant other health issues that might affect the study.
• Cannot have active infections or uncontrolled hepatitis or HIV.
• Cannot have had another cancer in the last 5 years, except for certain types.
• Cannot have completed a chemotherapy regimen within 3 weeks before starting the study.
• Cannot have had major surgery within 3 weeks before starting the study.
• Cannot have participated in another drug study within 4 weeks before starting the study.
• Cannot be receiving certain other cancer treatments or medications.
• Cannot be pregnant or breastfeeding.
• Must be able to comply with study requirements.