NCT01200212

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Taxane, Avastin	Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study
DRUG	Taxane, Avastin, Xeloda	Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 + Capecitabine 1800 mg/m2 day 1-14 q22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-09-13
• Last updated: 2013-05-22

Locations

1 site across 1 country: Germany