Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT01200212

Conditions

Breast Cancer

Interventions

Taxane, Avastin

Taxane, Avastin, Xeloda

Study Description

Brief 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.

Detailed Description: Primary Objective: - To determine the Progression Free Survival (PFS) in patients with metastatic breast cancer after treatment with taxane plus bevacizumab with (TXB) or without capecitabine (TB). Secondary Objective(s): * To determine the objective response rate in both arms. * To determine the duration of response in both arms. * To determine the Time to Progression (TTP) in both arms. * To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks in both arms. * To determine the overall survival rate 3 years after "Last Patient In". * To determine PFS and TTP response rates in patient's ≥ age 65. * To determine the toxicity and compliance in both arms. * To determine the predictive value of serum markers such as VEGF.