- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845910
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
-
-
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Kaohsiung, Taiwan, 807
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Taichung, Taiwan, 404
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Taichung, Taiwan, 407
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Taoyuan, Taiwan, 333
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-
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
|
7.5mg/kg iv on day 1 of every 3 week cycle
900mg/m2 po on days 1-14 of every 3 week cycle
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
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
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Capecitabine
- Bevacizumab
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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