Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Tucson , AZ 85704
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: July 7, 2008 at 2:34:17 PM


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