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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


Phase 2
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

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

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