A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Neoplasm Metastasis
Female
Breast Neoplasms, Neoplasm Metastasis
Trial Information
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Inclusion Criteria:
- Women aged greater than 18 years.
- Postmenopausal subjects
- Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or
radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint
Committee on Cancer Criteria)
Exclusion Criteria:
- Extensive visceral disease
- Subjects with bone as the only site of disease
- Prior radiation therapy to the site of measurable disease for subjects with a
solitary measurable lesion
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To determine overall progression free survival.
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3066A1-303
NCT ID:
NCT00083993
Start Date:
May 2004
Completion Date:
October 2006
Related Keywords:
- Breast Neoplasms
- Neoplasm Metastasis
- Breast Cancer
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Great Falls, Montana 59405 | |
| 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 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Lebanon, New Hampshire | |
| Charleston, West Virginia 25304 | |
| Washington, District of Columbia | |
| Las Vegas, Nevada 89109 | |
| Jackson, Mississippi | |
| Bismarck, North Dakota 58501 | |
| Salt Lake City, Utah 84112 | |
| Coeur D'alene, Idaho 83814 |
