Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
NCT ID: NCT00083993
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1236 participants
INTERVENTIONAL
2004-05-31
2006-10-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Temsirolimus (CCI-779) for 34 months
Letrozole for 34 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Hoover, Alabama, United States
Huntsville, Alabama, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Burbank, California, United States
Campbell, California, United States
Fountain Valley, California, United States
Gilroy, California, United States
Glendora, California, United States
Modesto, California, United States
Montebello, California, United States
Pomona, California, United States
Poway, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Soquel, California, United States
Vista, California, United States
Lakewood, Colorado, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Lake Worth, Florida, United States
Miami Shores, Florida, United States
New Port Richey, Florida, United States
Plantation, Florida, United States
Sarasota, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Roswell, Georgia, United States
Thomasville, Georgia, United States
Coeur d'Alene, Idaho, United States
Centralia, Illinois, United States
Skokie, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Munster, Indiana, United States
South Bend, Indiana, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Frederick, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Hattiesburg, Mississippi, United States
Rolla, Missouri, United States
Great Falls, Montana, United States
Omaha, Nebraska, United States
Carson City, Nevada, United States
Lebanon, New Hampshire, United States
Belleville, New Jersey, United States
Somerset, New Jersey, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
East Syracuse, New York, United States
New York, New York, United States
Nyack, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Gastonia, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Canton, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Mayfield Heights, Ohio, United States
Corvallis, Oregon, United States
Portland, Oregon, United States
Harrisburg, Pennsylvania, United States
Hershey, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Tyler, Texas, United States
Logan, Utah, United States
Ogden, Utah, United States
Arlington, Virginia, United States
Richmond, Virginia, United States
Woodbridge, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Calgary, Alberta, Canada
North Vancouver, British Columbia, Canada
Richmond, British Columbia, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Fleurimont, Quebec, Canada
Lévis, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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3066A1-303
Identifier Type: -
Identifier Source: org_study_id