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

Update Il y a 4 ans
Reference: EUCTR2006-006507-36

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMENS IN SUBJECTS WITH PREVIOUSLY TREATED 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 for previously treated MBC in subjects without brain metastasis as measured by PFS, assessed in a two-step, hierarchical manner, as follows: • Determination of the clinical benefit, as measured by PFS, of the addition of bevacizumab to non-capecitabine therapy, i.e., taxane (docetaxel, paclitaxel, paclitaxel protein-bound particles [Abraxane]), gemcitabine, or vinorelbine therapy compared with these chemotherapies alone in subjects receiving second-line therapy for MBC • Determination of the clinical benefit, as measured by PFS, of the addition of bevacizumab to any protocol-allowed chemotherapy (taxane, capecitabine, gemcitabine, or vinorelbine) compared with chemotherapy alone in subjects receiving second-line therapy for MBC


Inclusion criteria

  • Previously treated metastatic breast cancer