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.
- 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.
- 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.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (RECIST criteria)
Outcome Time Frame:
United States: Food and Drug Administration
- Breast Cancer
- Breast Neoplasms