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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

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00845910
First received: February 17, 2009
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: bevacizumab [Avastin]
Drug: docetaxel
Drug: capecitabine [Xeloda]
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: At planned visits, till disease progression ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2009
Estimated Study Completion Date: December 2012
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of every 3 week cycle
Drug: docetaxel
60mg/m2 iv on day 1 of every 3 week cycle
Drug: capecitabine [Xeloda]
900mg/m2 po on days 1-14 of every 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845910

Locations
Taiwan
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00845910     History of Changes
Other Study ID Numbers: ML21870
Study First Received: February 17, 2009
Last Updated: January 17, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013