Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry NO17328 NCT00337649

Trial Description

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00337649
Information obtained from ClinicalTrials.gov on September 18, 2008