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 \< 300 mg/m2 prior doxorubicin or \< 450 mg/m2 prior epirubicin
• •Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.
• •Has an ECOG Performance Status (PS) 0-2 (see Appendix I)
• •Is a male or female greater than or equal to 18 years of age
• •Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.
• •Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential \[WOCBP; not surgically sterilized and between menarche and 1 year postmenopause\])
• •If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
• •Has signed a Patient Informed Consent Form
• •Has signed a Patient Authorization Form (HIPAA Form)
• •Has a life expectancy of \> 3 months