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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00845910

Enrollment

Registered

2009-02-18

Start date

2009-05-31

Completion date

2011-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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 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.

Interventions

DRUGbevacizumab [Avastin]

7.5mg/kg iv on day 1 of every 3 week cycle

DRUGcapecitabine [Xeloda]

900mg/m2 po on days 1-14 of every 3 week cycle

DRUGdocetaxel

60mg/m2 iv on day 1 of every 3 week cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Overall response rate	Every 12 weeks

Secondary

Measure	Time frame
Time to disease progression	Event driven
Serious adverse events	At planned visits, till disease progression

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026