Trial Information

Summary: (BRAVE Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Metastatic Breast Cancer

Status: Completed

Protocol Number: BA16756

Sponsor: Hoffman-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of NeoRecormon on overall survival in patients with metastatic breast cancer.

Brief Summary: This study will compare the outcome of treatment with or without NeoRecormon in patients with metastatic breast cancer undergoing chemotherapy. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is 460.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Anemia

Intervention Type: Drug

Intervention Name: epoetin beta[NeoRecormon]

Primary Outcome: 1. Efficacy: Overall survival

Key Secondary Outcomes: 1. Efficacy: Serial tumor measurements, serial Hb determinations, documentation of transfusion, chemotherapy dose and dose adjustments. Safety: Adverse events, lab tests, C-reactive protein, iron parameters, blood pressure.

Inclusion Criteria:

  • women >=18 years of age;
  • metastatic breast cancer;
  • scheduled to begin either anthracycline- and/or taxane-based chemotherapy.

Exclusion Criteria:

  • women who are pregnant, lactating, or unwilling to use a reliable contraceptive method;
  • treatment with epoetin or other erythropoietic substance in 2 months before study;
  • patients who have participated in the active phase of another investigational drug study in the 4 weeks prior to screening, or are scheduled to participate in the active phase of another investigational drug study during the treatment period.

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Leuven, Belgium, 3000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:04:33 PM


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