A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
Inclusion Criteria:
- women >=18 years of age;
- >=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- >=2 regimens of chemotherapy for advanced/metastatic disease.
Exclusion Criteria:
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral
fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to Progression of Disease or Death
Outcome Description:
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
Outcome Time Frame:
Event driven (after 350 events). Median observation time was approximately 16 months.
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO16853
NCT ID:
NCT00077857
Start Date:
July 2003
Completion Date:
March 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Bettendorf, Iowa 52722 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Kansas City, Kansas 66160 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| South Burlington, Vermont | |
| Indianapolis, Indiana | |
| Charleston, South Carolina |
