A MULTICENTER, PHASE III, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMENS IN SUBJECTS WITH PREVIOUSLY UNTREATED METASTA...

Update Il y a 4 ans
Reference: EUCTR2006-000378-61

A MULTICENTER, PHASE III, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMENS IN SUBJECTS WITH PREVIOUSLY UNTREATED METASTATIC BREAST CANCER

Woman and Man

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Extract

The primary objective of the study is to determine the clinical benefit of the addition of bevacizumab to standard chemotherapy regimens for previously untreated metastatic breast cancer, as measured by PFS based on investigator tumor assessment, assessed in a parallel manner as follows: • Determination of the clinical benefit, as measured by PFS based on investigator tumor assessment, of the addition of bevacizumab to taxane therapy (docetaxel or paclitaxel protein-bound particles [Abraxane] administered every 3 weeks) and anthracycline-based therapy, compared with these chemotherapies alone, in subjects who are receiving first-line therapy for locally recurrent or metastatic breast cancer • Determination of the clinical benefit, as measured by PFS based on investigator tumor assessment, of the addition of bevacizumab to capecitabine therapy compared with capecitabine therapy alone, in subjects who are receiving first-line therapy for locally recurrent or metastatic breast cancer


Inclusion criteria

  • Metastatic breast cancer