Trial information
A Study of Epothilone D in Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: NO17319
Sponsor: Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of intravenous Epothilone D on treatment response in patients with metastatic breast cancer
Brief summary: This study will assess the efficacy and safety of repeated cycles of intravenous Epothilone D in patients with metastatic breast cancer. The anticipated time on study treatment is until evidence of progressive disease, and the target sample size is <100 individuals.
Target sample size is
63.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: Epothilone D
Primary outcome: 1. Efficacy: Response rate, duration of response
Key secondary outcomes: 1. Safety: Adverse events, neurological evaluations and laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- metastatic breast cancer;
- failure of previous treatment with both a taxane and an anthracycline;
- <=2 prior regimens for metastatic disease (except hormonal therapy).
Exclusion criteria:
- women who are pregnant, breastfeeding, or unwilling to use an effective contraceptive method;
- central nervous system metastases;
- pre-existing neuropathy;
- previous malignancy, unless free of recurrence for at least 5 years.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Scarborough, ME
- Detroit, MI
- Cleveland, OH
