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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Desoxyepothilone B; Epothilones; Trastuzumab

Criteria

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.