Trial Information

Summary: A Study of Avastin (Bevacizumab) plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Status: Recruiting

Protocol Number: MO19391

Sponsor: F. Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open-label study to evaluate the safety and effect on disease progression and overall survival of Avastin plus taxane-based chemotherapy in patients with locally recurrent or metastatic breast cancer

Brief Summary: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. Target sample size is 2300.

Study Phase: III

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: bevacizumab [Avastin]

Primary Outcome: 1. Incidence of AEs, and SAEs related to Avastin Time frame: Throughout study

Key Secondary Outcomes: 1. Duration of survival, time to disease progression Time frame: Event driven

Inclusion Criteria:

  • patients, >=18 years of age;
  • HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
  • candidates for chemotherapy.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • concomitant hormonal therapy for metastatic or locally recurrent disease;
  • concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
  • previous radiotherapy for treatment of metastatic disease;
  • evidence of CNS metastases.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2006

Trial Registration Date: 07/19/2006

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
East Melbourne, Australia, 3002
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:49:16 PM


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