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

Roche

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845910

ML21870

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

1

Experimental group

Treatment:

Drug: docetaxel

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]