Ixabepilone + Carboplatin Metastatic Breast Cancer

Inclusion Criteria

• •Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:
• •1. Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease
• •2. Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as ≥20 mm with conventional techniques (CT, MRI, X-ray) or as ≥10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.
• •3. Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:
• ••Has had no prior treatment with ixabepilone or platinum agents
• •4. Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy
• •5. 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to \<Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to \<Grade 1 (if applicable).
• •6. Has an ECOG Performance Status (PS) 0-2
• •7. Is ≥18 years of age
• •8. Has a life expectancy of at least 12 weeks
• •9. Has laboratory values of:
• •White blood cell (WBC) count ≥3000 x 106/L Absolute neutrophil count (ANC) ≥1500 x 106/L Hemoglobin ≥9 g/dL Total bilirubin ≤1x upper limit of normal (ULN) AST and ALT ≤2.5 x ULN Alkaline phosphatase ≤2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine ≤1.5 mg/dL Calculated creatinine clearance \>50 mL/min (based on Cockroft and Gault method \[Appendix III\]) Platelet count ≥100,000 x 106/L
• •10. If patient has had radiation therapy, it has been completed \>3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.
• •11. Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential \[not surgically sterilized and between menarche and 1 year postmenopause
• •12. If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
• •13. Has signed the most recent Patient Informed Consent Form
• •14. Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.