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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

GBG Forschungs GmbH · 2009
ClinicalTrials.gov · Datasets · License: Public Domain · 2009
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breast-cancermetastatic-breast-canceroverall-survivalprogression-free-survival
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.
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