Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
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
1 other identifier
interventional
1,236
2 countries
129
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 4, 2004
CompletedFirst Posted
Study publicly available on registry
June 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedNovember 8, 2011
November 1, 2011
2.4 years
June 4, 2004
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine overall progression free survival.
Secondary Outcomes (1)
To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
Unknown Facility
Hoover, Alabama, 35216, United States
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Huntsville, Alabama, 35801, United States
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Tucson, Arizona, 85715, United States
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Jonesboro, Arkansas, 72401, United States
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Burbank, California, 91505, United States
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Campbell, California, 95008, United States
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Fountain Valley, California, 92708, United States
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Gilroy, California, 95020, United States
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Glendora, California, 91740, United States
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Modesto, California, 95355, United States
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Montebello, California, 90640, United States
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Pomona, California, 91767, United States
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Poway, California, 92064, United States
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Sacramento, California, 95816, United States
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San Diego, California, 92123, United States
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Santa Rosa, California, 95405, United States
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Soquel, California, 95073, United States
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Vista, California, 92083, United States
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Lakewood, Colorado, 80215, United States
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Norwalk, Connecticut, 06851, United States
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Washington D.C., District of Columbia, 20010, United States
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Boca Raton, Florida, 33428, United States
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Fort Lauderdale, Florida, 33305, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville, Florida, 32224, United States
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Lake Worth, Florida, 33461, United States
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Miami Shores, Florida, 33138, United States
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New Port Richey, Florida, 34652, United States
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Plantation, Florida, 33324, United States
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Sarasota, Florida, 34239, United States
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Zephyrhills, Florida, 33542, United States
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Atlanta, Georgia, 30309-1710, United States
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Columbus, Georgia, 31902, United States
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Roswell, Georgia, 30076, United States
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Thomasville, Georgia, 31792, United States
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Coeur d'Alene, Idaho, 83814, United States
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Centralia, Illinois, 62801, United States
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Skokie, Illinois, 60076, United States
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Skokie, Illinois, 60077, United States
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Springfield, Illinois, 62702, United States
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Urbana, Illinois, 61801, United States
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Munster, Indiana, 46321, United States
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South Bend, Indiana, 46601, United States
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Lexington, Kentucky, 40504, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21231, United States
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Baltimore, Maryland, 21237, United States
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Bethesda, Maryland, 20817, United States
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Frederick, Maryland, 21701, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02118, United States
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Boston, Massachusetts, 02135, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48202, United States
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Flint, Michigan, 48503, United States
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Grand Rapids, Michigan, 49503, United States
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Grand Rapids, Michigan, 49546, United States
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Minneapolis, Minnesota, 55455, United States
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Hattiesburg, Mississippi, 39401, United States
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Rolla, Missouri, 65401, United States
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Great Falls, Montana, 59406, United States
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Omaha, Nebraska, 68198, United States
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Carson City, Nevada, 89703, United States
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Lebanon, New Hampshire, 03756, United States
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Belleville, New Jersey, 07109, United States
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Somerset, New Jersey, 08873, United States
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Albuquerque, New Mexico, 87109, United States
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Binghamton, New York, 13905, United States
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East Syracuse, New York, 13057, United States
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New York, New York, 10032, United States
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Nyack, New York, 10960, United States
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Staten Island, New York, 10305, United States
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Charlotte, North Carolina, 28203, United States
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Gastonia, North Carolina, 28054, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58504, United States
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Canton, Ohio, 44710, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45238, United States
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Cleveland, Ohio, 44106-5055, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43235, United States
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Mayfield Heights, Ohio, 44124, United States
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Corvallis, Oregon, 97330, United States
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Portland, Oregon, 97213, United States
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Harrisburg, Pennsylvania, 17110, United States
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Hershey, Pennsylvania, 17033, United States
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Langhorne, Pennsylvania, 19047, United States
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Philadelphia, Pennsylvania, 19106, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Charleston, South Carolina, 29425, United States
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Columbia, South Carolina, 29169, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37205, United States
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Arlington, Texas, 76012, United States
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Corpus Christi, Texas, 78412, United States
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Dallas, Texas, 75230, United States
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Fort Worth, Texas, 76104, United States
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Irving, Texas, 75038, United States
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Tyler, Texas, 75701, United States
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Logan, Utah, 84341, United States
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Ogden, Utah, 84403, United States
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Arlington, Virginia, 22205-3637, United States
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Richmond, Virginia, 23294, United States
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Woodbridge, Virginia, 22191, United States
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Seattle, Washington, 98101, United States
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Morgantown, West Virginia, 26505, United States
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Calgary, Alberta, T2N4N2, Canada
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North Vancouver, British Columbia, V7L 2L7, Canada
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Richmond, British Columbia, V6X1A2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Toronto, Ontario, M4C-3E7, Canada
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Toronto, Ontario, M4N 3N5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M5G 2m9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Fleurimont, Quebec, J1H 5N4, Canada
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Lévis, Quebec, G1V3Z1, Canada
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Pointe-Claire, Quebec, H9R4S3, Canada
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Québec, Quebec, G1R2J6, Canada
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Saskatoon, Saskatchewan, S7N4H4, Canada
Related Publications (1)
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.
PMID: 23233719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2004
First Posted
June 8, 2004
Study Start
May 1, 2004
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
November 8, 2011
Record last verified: 2011-11