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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Active

18 and over

Pharmaceutical / Industry

MO19391
NCT00448591

Trial Description

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Please reference Study ID Number: PDO_MO19391

Ph: 973-235-5000

Ph: 800-526-6367 (FOR US ONLY)

Trial Sites

China

BEIJING

Study Site

CHANG SHA

Study Site

CHANGCHUN

Study Site

CHENGDU

Study Site

CHONGQING

Study Site

GUANGZHOU

Study Site

HANG ZHOU

Study Site

HE FEI

Study Site

NANJING

Study Site

SHANGHAI

Study Site

SUZHOU

Study Site

TIANJIN

Study Site

Russia

BALASHIKHA

Study Site

BARNAUL

Study Site

ENGELS

Study Site

IRKUTSK

Study Site

IZHEVSK

Study Site

KAZAN

Study Site

KURSK

Study Site

STAVROPOL

Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00448591
Information obtained from ClinicalTrials.gov on September 18, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.