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Clinical Trials (PDQ®)

A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overPharmaceutical / IndustryBO17708
2005-003862-40, NCT00333775

Trial Description

Summary

This study will evaluate the efficacy and safety of 2 doses of Avastin in combin ation with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy bu t who have not received prior chemotherapy for metastatic disease. The anticipat ed time on treatment is 1-2 years and the target sample size is 500+ individuals

Eligibility Criteria

Inclusion Criteria:

  • female patients >= 18 years of age;
  • HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
  • no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • radiotherapy for treatment of metastatic disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • spinal cord compression or brain metastases;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
  • inadequate bone marrow, liver or renal function;
  • uncontrolled hypertension.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00333775
ClinicalTrials.gov processed this data on December 15, 2014

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.

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