Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Inclusion Criteria:

• Confirmed adenocarcinoma of the breast
• Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
• Stage IV disease
• Measurable disease
• At least 3 weeks since prior cytotoxic chemotherapy
• At least 4 weeks since radiotherapy with full recovery
• At least 4 weeks since major surgery with full recovery
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• At least 18 years old
• Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L
• Platelets at least 100 x 10^9 cells/L
• Hemoglobin at least 9 g/dL
• Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
• Alkaline Phosphatase less than 1.5X upper limit normal
• Creatinine less than 1.5 gm/dL
• Normal left ventricular ejection fraction
• Negative pregnancy test
• Agree to use method to avoid pregnancy
• Informed Consent is obtained

Exclusion Criteria:

• Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
• Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
• Concurrent immunotherapy or hormonal therapy
• Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
• Serious intercurrent medical or psychiatric illness, including serious active infection
• History of congestive heart failure
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
• Patients who have received an investigational drug within the previous 3 weeks
• Patient is currently enrolled in another clinical study receiving investigational therapies
• Pregnant or nursing women