PhII ICb With/Without Erbitux in MBC Pts

Exclusion Criteria

• •Has Stage I-III breast cancer or nonmeasurable metastatic breast cancer, or any disease other than that described in inclusion criterion #1
• •Has received prior treatment with irinotecan, carboplatin, or cisplatin
• •Is receiving any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)
• •Has received prior therapy which specifically and directly targets the EGFR pathway. Prior Herceptin is required for HER2+ patients.
• •Has had prior severe infusion reaction to a monoclonal antibody
• •Has received organ allograft(s) other than corneal, bone, or skin
• •Has clinically significant uncontrolled cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmias not well-controlled with medication) or has had a myocardial infarction \< 12 months
• •Has ongoing peripheral neuropathy \> Grade I
• •Has evidence of symptomatic or untreated central nervous system (CNS) metastases (unless CNS metastases have been irradiated). Chronic steroid treatment for the treatment of CNS metastases must have been discontinued for greater than 4 weeks prior to study enrollment.
• •Has any other significant comorbidity that, in the opinion of the clinical investigator, might compromise any aspect of the study
• •Has active or uncontrolled infection
• •Has acute hepatitis or is known to be HIV positive
• •Has a history of other malignancy within the last 5 years which could affect the diagnosis or assessment of MBC, with the exception of carcinoma of the cervix in situ, carcinoma of the bladder in situ, and basal cell carcinoma
• •Has previously completed a chemotherapy regimen within 3 weeks prior to the start of study treatment, or has related toxicities unresolved prior to the start of study treatment
• •NOTE: If patient was receiving prior weekly or daily chemotherapy, he/she may begin study therapy 2 weeks after stopping prior therapy provided all toxicities have resolved; peripheral neuropathy must be less than Grade I as per exclusion criterion #8 above.
• •Has had major surgery within 3 weeks from the start of study treatment, without complete recovery
• •Has participated in any investigational drug study within 4 weeks preceding the start of study treatment
• •Has received a concurrent immunotherapy or hormonal anticancer agent within 2 weeks prior to the start of the study treatment
• •Is receiving a tyrosine kinase inhibitor (ie, IressaTM)
• •Has had any prior stem cell or bone marrow transplant for any prior hematologic malignancy
• •Is pregnant or lactating
• •Is unable to comply with the requirements of the study