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

• Status: Terminated
• Trial end date: 2012-10-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: German Breast Group
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Capecitabine; Docetaxel; Paclitaxel; Taxane