Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
Every 12 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Taiwan: Department of Health
Study ID:
ML21870
NCT ID:
NCT00845910
Start Date:
May 2009
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms