Status:

TERMINATED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-65 years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2011

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT00845910

Start Date

May 1 2009

End Date

May 1 2011

Last Update

November 2 2016

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Kaohsiung City, Taiwan, 807

2

Taichung, Taiwan, 404

3

Taichung, Taiwan, 407

4

Taoyuan District, Taiwan, 333