Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Inclusion Criteria

• Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease
• Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.
• Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study
• Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy
• For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC
• For taxane-naïve patients, has had no prior chemotherapy for MBC
• Has had cumulative doses of 3 months

Exclusion Criteria

• Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
• Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil
• Has evaluable only disease; eg, bone only, pleural, peritoneal only disease
• Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.
• Is receiving concurrent investigational therapy or has received such therapy within 30 days
• Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease
• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
• Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
• Is a pregnant or lactating woman
• Is unable to comply with requirements of study