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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
      • Taichung, Taiwan, 404
      • Taichung, Taiwan, 407
      • Taoyuan, Taiwan, 333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Every 12 weeks
Every 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: Event driven
Event driven
Serious adverse events
Time Frame: At planned visits, till disease progression
At planned visits, till disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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