A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Inclusion Criteria:

• women >=18 years;
• locally advanced or metastatic breast cancer;
• HER-2 overexpression (FISH + or IHC 3+);
• >=1 measurable lesion;
• up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Exclusion Criteria:

• pre-existing neuropathy >=grade 2;
• known CNS metastases;
• congestive heart failure, or myocardial infarction within the last 6 months;
• previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.