An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
An Open-label Study of Xeloda Plus Avastin at Time of Disease Progression in Treatment-naïve Women With HER2-negative Metastatic Breast Cancer
Inclusion Criteria:
- Women >=18 years of age
- HER2-negative metastatic breast cancer
- Previous adjuvant chemotherapy or hormonal treatment
- >=1 measurable target lesion
Exclusion Criteria:
- Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy
for advanced or metastatic cancer
- Radiation therapy within 4 weeks of study treatment start or insufficient recovery
from the effects of prior radiation therapy
- Central nervous system metastases
- Other malignancy within last 5 years, except cured basal cell carcinoma of skin and
carcinoma in situ of uterine cervix
- Serious concurrent infection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death
Outcome Time Frame:
approximately 505 days (Median Time to Death)
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:
ML18527
NCT ID:
NCT00121836
Start Date:
June 2005
Completion Date:
December 2008
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Scarborough, Maine 04074 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Las Vegas, Nevada 89109 |
