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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

NCT ID: NCT00845910

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

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

capecitabine [Xeloda]

Intervention Type DRUG

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

docetaxel

Intervention Type DRUG

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

Interventions

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bevacizumab [Avastin]

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

Intervention Type DRUG

capecitabine [Xeloda]

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

Intervention Type DRUG

docetaxel

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML21870

Identifier Type: -

Identifier Source: org_study_id