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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

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ClinicalTrials.gov Identifier: NCT00845910
Recruitment Status : Terminated (To be confirmed)
First Posted : February 18, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bevacizumab [Avastin] Drug: capecitabine [Xeloda] Drug: docetaxel Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Every 12 weeks ]

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: Event driven ]
  2. Serious adverse events [ Time Frame: At planned visits, till disease progression ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845910

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00845910     History of Changes
Other Study ID Numbers: ML21870
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic