Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Capecitabine
Docetaxel/Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast, Cancer, Early-Stage, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed breast carcinoma.
- Early stage breast cancer (stage 1, 2, 3).
- No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- 18 years of age or older.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion Criteria:
- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- Major surgery within 28 days of study entry.
- Evidence of CNS metastases.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Sites / Locations
- Grady Memorial HospitalRecruiting
- Emory Crawford Long HospitalRecruiting
- Winship Cancer Institute of Emory UniversityRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00415285
First Posted
December 20, 2006
Last Updated
February 12, 2007
Sponsor
Georgia Center for Oncology Research & Education
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00415285
Brief Title
Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
Official Title
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Georgia Center for Oncology Research & Education
Collaborators
Sanofi
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Detailed Description
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.
Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast, Cancer, Early-Stage, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Docetaxel/Capecitabine
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed breast carcinoma.
Early stage breast cancer (stage 1, 2, 3).
No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
18 years of age or older.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion Criteria:
Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
Major surgery within 28 days of study entry.
Evidence of CNS metastases.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Johnson
Phone
404-778-7777
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth O'Regan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Johnson
Phone
404-778-7777
First Name & Middle Initial & Last Name & Degree
Ruth O'Regan
Facility Name
Emory Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Johnson
Phone
404-778-7777
First Name & Middle Initial & Last Name & Degree
Ruth O'Regan
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Johnson
Phone
404-778-7777
First Name & Middle Initial & Last Name & Degree
Ruth O'Regan
12. IPD Sharing Statement
Links:
URL
http://www.georgiacore.org
Description
Georgia Center for Oncology Research and Education
URL
http://www.winshipcancerinstitute.org/
Description
Winship Cancer Institute
Learn more about this trial
Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
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