Phase II Study in Patients With Operable Breast Cancer

A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu

The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.

Inclusion Criteria:

• Dx of clinical T1c-T3, N0-1, M0 breast cancer
• Interval between diagnosis and consent of <- 62 days
• Life expectancy of 10 years
• LVEF by MUGA >= lower limit of normal for the testing facility
• Negative serum pregnancy test
• Adequate bone marrow, renal, liver function
• Negative bone scan
• HRT discontinued before study entry
• Adequate contraceptive methods

Exclusion Criteria:

• Male breast cancer
• Less than 21 years of age
• Ulceration, infiltration of the skin, complete fixation or severe skin edema
• N3 disease in which nodes are matted and fixed
• Suspicious palpable supraclavicular nodes
• CT evidence of malignant internal mammary nodes
• Pregnancy or breast feeding at time of study entry
• Prior therapy for breast cancer
• Prior anthracycline for any malignancy
• Prior breast malignancy of the contralateral breast
• Prior non-breast malignancy within 5 years
• Non-malignant disease that would preclude follow up
• MI within 6 months, NYHA Class II or greater heart failure
• Psychiatric disorders or conditions that would preclude provision of informed consent