A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: docetaxel

• Registration Number: NCT00845910
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Study Start: 2009-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• female patients, 18-65 years of age;
• locally recurrent and metastatic breast cancer;
• measurable or evaluable disease;
• ECOG performance status of 0-2;
• LVEF >=50% without clinical symptoms or signs of heart failure.

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Exclusion Criteria

• unknown HER2 status, or known HER2-positive status;
• prior chemotherapy for locally recurrent or metastatic disease;
• prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
• clinical or radiological evidence of CNS metastases;
• clinically significant cardiovascular disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	capecitabine [Xeloda]	-
1	docetaxel	-
1	bevacizumab [Avastin]	-

Primary Outcome Measures

Name	Time	Method
Overall response rate	Every 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	Event driven
Serious adverse events	At planned visits, till disease progression