Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
NCT00083993
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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)
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Duarte, California
- Santa Monica, California
- Tampa, Florida
- Cleveland, Ohio
- Darlinghurst, New South Wales
- Dijon,
- Saint-Herblain,
- Pokfulam,
- Floriana,
- Lodz,
- Wroclaw,
- Moscow,
- Dnipropetrovsk,
- Sumy,
- Uzhgorod,
- Hoover, Alabama
- Huntsville, Alabama
- Tucson, Arizona
- Jonesboro, Arkansas
- Burbank, California
- Campbell, California
- Fountain Valley, California
- Gilroy, California
- Glendora, California
- Modesto, California
- Montebello, California
- Pomona, California
- Poway, California
- Sacramento, California
- San Diego, California
- Santa Rosa, California
- Soquel, California
- Vista, California
- Lakewood, Colorado
- Norwalk, Connecticut
- Washington, District of Columbia
- Boca Raton, Florida
- Fort Lauderdale, Florida
- Hollywood, Florida
- Jacksonville, Florida
- Jacksonville, Florida
- Lake Worth, Florida
- Miami Shores, Florida
- New Port Richey, Florida
- Plantation, Florida
- Sarasota, Florida
- Zephyrhills, Florida
- Atlanta, Georgia
- Columbus, Georgia
- Roswell, Georgia
- Thomasville, Georgia
- Coeur d'Alene, Idaho
- Centralia, Illinois
- Skokie, Illinois
- Skokie, Illinois
- Springfield, Illinois
- Urbana, Illinois
- Munster, Indiana
- South Bend, Indiana
- Lexington, Kentucky
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Bethesda, Maryland
- Frederick, Maryland
- Towson, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Flint, Michigan
- Grand Rapids, Michigan
- Grand Rapids, Michigan
- Minneapolis, Minnesota
- Hattiesburg, Mississippi
- Rolla, Missouri
- Great Falls, Montana
- Omaha, Nebraska
- Carson City, Nevada
- Lebanon, New Hampshire
- Belleville, New Jersey
- Somerset, New Jersey
- Albuquerque, New Mexico
- Binghamton, New York
- East Syracuse, New York
- New York, New York
- Nyack, New York
- Staten Island, New York
- Charlotte, North Carolina
- Gastonia, North Carolina
- Wilmington, North Carolina
- Winston-Salem, North Carolina
- Bismark, North Dakota
- Canton, Ohio
- Canton, Ohio
- Cincinnati, Ohio
- Cincinnati, Ohio
- Cleveland, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Mayfield Heights, Ohio
- Corvallis, Oregon
- Portland, Oregon
- Harrisburg, Pennsylvania
- Hershey, Pennsylvania
- Langhorne, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Columbia, South Carolina
- Chattanooga, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Arlington, Texas
- Corpus Christi, Texas
- Dallas, Texas
- Fort Worth, Texas
- Irving, Texas
- Tyler, Texas
- Logan, Utah
- Ogden, Utah
- Arlington, Virginia
- Richmond, Virginia
- Woodbridge, Virginia
- Seattle, Washington
- Morgantown, West Virginia
- Calgary, Alberta
- North Vancouver, British Columbia
- Richmond, British Columbia
- Halifax, Nova Scotia
- Barrie, Ontario
- Hamilton, Ontario
- Newmarket, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Chicoutimi, Quebec
- Fleurimont, Quebec
- Levis, Quebec
- Pointe Claire, Quebec
- Quebec City, Quebec
- Saskatoon, Saskatchewan
- Manhasset, New York
- New York, New York
- Cleveland, Ohio
- Cleveland, Ohio
- Orange Village, Ohio
- Westlake, Ohio
- Nashville, Tennessee
- East Bentleigh, Victoria
- Parkville, Victoria
- Brussel,
- Charleroi,
- Haine St. Paul,
- Leuven,
- Wilrijk,
- Dijon,
- Montpellier,
- Paris,
- Toulouse Cedex,
- Vandoeuvre Les Nancy,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer | |||
Official Title ICMJE | 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 | |||
Brief Summary | In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, Sun Y, Neskovic-Konstantinovic Z, Guimaraes RC, Fumoleau P, Chan A, Hachemi S, Strahs A, Cincotta M, Berkenblit A, Krygowski M, Kang LL, Moore L, Hayes DF. Randomized phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013 Jan 10;31(2):195-202. doi: 10.1200/JCO.2011.38.3331. Epub 2012 Dec 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | 1236 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | October 2006 | |||
Actual Primary Completion Date | October 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00083993 | |||
Other Study ID Numbers ICMJE | 3066A1-303 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | November 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |