Back to resultsA 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
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
bevacizumab [Avastin]
capecitabine [Xeloda]
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Time to disease progression
Serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00845910
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
To be confirmed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5mg/kg iv on day 1 of every 3 week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
900mg/m2 po on days 1-14 of every 3 week cycle
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
60mg/m2 iv on day 1 of every 3 week cycle
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Every 12 weeks
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
Event driven
Title
Serious adverse events
Time Frame
At planned visits, till disease progression
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
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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