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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00845910
• Other study ID #: ML21870
• Status: Terminated
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: November 1, 2016
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
7.5mg/kg iv on day 1 of every 3 week cycle
• capecitabine [Xeloda]
900mg/m2 po on days 1-14 of every 3 week cycle
• docetaxel
60mg/m2 iv on day 1 of every 3 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Every 12 weeks	No
Secondary	Time to disease progression		Event driven	No
Secondary	Serious adverse events		At planned visits, till disease progression	No