A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer

Hoffmann-La Roche0 sites22 target enrollmentMay 2009

ConditionsBreast Cancer

Interventionsbevacizumab [Avastin]capecitabine [Xeloda]docetaxel

Drugsbevacizumab [Avastin]capecitabine [Xeloda]docetaxel

Overview

Phase: Phase 2
Intervention: bevacizumab [Avastin]
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 22
Primary Endpoint: Overall response rate
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

May 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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.

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.