A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

Summary

The purpose of this study is to determine whether * Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab. * As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated. * Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice. * Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy. * Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months. * Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.

Timeline

Start

2009-07

Primary completion

2012-10

Completion

2012-10

Outcome

Outcome not reported

Stopped: “A planed interim analysis shows no benefits, but higher adverse event rates for the experimental arm.”

Drugs

Indications