- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083993
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N4N2
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British Columbia
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North Vancouver, British Columbia, Canada, V7L 2L7
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Richmond, British Columbia, Canada, V6X1A2
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
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Hamilton, Ontario, Canada, L8V 5C2
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Newmarket, Ontario, Canada, L3Y 2P9
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M5G 1X5
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Toronto, Ontario, Canada, M4C-3E7
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Toronto, Ontario, Canada, M4N 3N5
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Fleurimont, Quebec, Canada, J1H 5N4
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Levis, Quebec, Canada, G1V3Z1
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Pointe Claire, Quebec, Canada, H9R4S3
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Quebec City, Quebec, Canada, G1R2J6
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N4H4
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Alabama
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Hoover, Alabama, United States, 35216
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Huntsville, Alabama, United States, 35801
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Arizona
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Tucson, Arizona, United States, 85715
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Arkansas
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Jonesboro, Arkansas, United States, 72401
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California
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Burbank, California, United States, 91505
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Campbell, California, United States, 95008
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Fountain Valley, California, United States, 92708
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Gilroy, California, United States, 95020
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Glendora, California, United States, 91740
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Modesto, California, United States, 95355
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Montebello, California, United States, 90640
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Pomona, California, United States, 91767
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Poway, California, United States, 92064
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Sacramento, California, United States, 95816
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San Diego, California, United States, 92123
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Santa Rosa, California, United States, 95405
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Soquel, California, United States, 95073
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Vista, California, United States, 92083
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Colorado
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Lakewood, Colorado, United States, 80215
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Connecticut
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Norwalk, Connecticut, United States, 06851
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District of Columbia
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Washington, District of Columbia, United States, 20010
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Florida
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Boca Raton, Florida, United States, 33428
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Fort Lauderdale, Florida, United States, 33305
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32209
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Jacksonville, Florida, United States, 32224
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Lake Worth, Florida, United States, 33461
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Miami Shores, Florida, United States, 33138
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New Port Richey, Florida, United States, 34652
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Plantation, Florida, United States, 33324
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Sarasota, Florida, United States, 34239
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Zephyrhills, Florida, United States, 33542
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Georgia
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Atlanta, Georgia, United States, 30309-1710
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Columbus, Georgia, United States, 31902
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Roswell, Georgia, United States, 30076
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Thomasville, Georgia, United States, 31792
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Idaho
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Coeur d'Alene, Idaho, United States, 83814
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Illinois
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Centralia, Illinois, United States, 62801
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Skokie, Illinois, United States, 60076
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Skokie, Illinois, United States, 60077
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Springfield, Illinois, United States, 62702
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Urbana, Illinois, United States, 61801
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Indiana
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Munster, Indiana, United States, 46321
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South Bend, Indiana, United States, 46601
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Kentucky
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Lexington, Kentucky, United States, 40504
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Maryland
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Baltimore, Maryland, United States, 21201
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Baltimore, Maryland, United States, 21237
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Baltimore, Maryland, United States, 21231
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Bethesda, Maryland, United States, 20817
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Frederick, Maryland, United States, 21701
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Towson, Maryland, United States, 21204
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Massachusetts
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Boston, Massachusetts, United States, 02135
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Boston, Massachusetts, United States, 02118
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Michigan
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Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48202
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Flint, Michigan, United States, 48503
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Grand Rapids, Michigan, United States, 49503
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Grand Rapids, Michigan, United States, 49546
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Minnesota
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Minneapolis, Minnesota, United States, 55455
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
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Missouri
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Rolla, Missouri, United States, 65401
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Montana
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Great Falls, Montana, United States, 59406
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Nebraska
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Omaha, Nebraska, United States, 68198
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Nevada
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Carson City, Nevada, United States, 89703
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
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New Jersey
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Belleville, New Jersey, United States, 07109
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Somerset, New Jersey, United States, 08873
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New Mexico
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Albuquerque, New Mexico, United States, 87109
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New York
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Binghamton, New York, United States, 13905
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East Syracuse, New York, United States, 13057
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New York, New York, United States, 10032
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Nyack, New York, United States, 10960
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Staten Island, New York, United States, 10305
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North Carolina
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Charlotte, North Carolina, United States, 28203
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Gastonia, North Carolina, United States, 28054
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
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North Dakota
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Bismark, North Dakota, United States, 58504
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Ohio
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Canton, Ohio, United States, 44718
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Canton, Ohio, United States, 44710
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Cincinnati, Ohio, United States, 45219
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Cincinnati, Ohio, United States, 45238
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Cleveland, Ohio, United States, 44195
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Cleveland, Ohio, United States, 44106-5055
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Columbus, Ohio, United States, 43215
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Columbus, Ohio, United States, 43235
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Mayfield Heights, Ohio, United States, 44124
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Oregon
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Corvallis, Oregon, United States, 97330
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Portland, Oregon, United States, 97213
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17110
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Hershey, Pennsylvania, United States, 17033
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Langhorne, Pennsylvania, United States, 19047
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Philadelphia, Pennsylvania, United States, 19106
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Pittsburgh, Pennsylvania, United States, 15213
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South Carolina
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29169
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37205
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Texas
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Arlington, Texas, United States, 76012
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Corpus Christi, Texas, United States, 78412
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Dallas, Texas, United States, 75230
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Fort Worth, Texas, United States, 76104
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Irving, Texas, United States, 75038
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Tyler, Texas, United States, 75701
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Utah
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Logan, Utah, United States, 84341
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Ogden, Utah, United States, 84403
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Virginia
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Arlington, Virginia, United States, 22205-3637
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Richmond, Virginia, United States, 23294
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Woodbridge, Virginia, United States, 22191
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Washington
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Seattle, Washington, United States, 98101
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West Virginia
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Morgantown, West Virginia, United States, 26505
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine overall progression free survival.
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Secondary Outcome Measures
Outcome Measure |
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To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms by Site
- Breast Diseases
- Neoplastic Processes
- Neoplasms
- Breast Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Hormone Antagonists
- Antifungal Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
- Sirolimus
Other Study ID Numbers
- 3066A1-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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