Study Evaluating CCI-779 and Letrozole in Post-Menopausal Women With Breast Cancer

Condition(s) targeted: Breast Neoplasms; Neoplasm Metastasis

Intervention: Temsirolimus (CCI-779) for 34 months (Drug); Letrozole for 34 months (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To determine overall progression free survival.

Secondary outcome: To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Hoover, Alabama 35216, United States

Huntsville, Alabama 35801, United States

Calgary, Alberta T2N4N2, Canada

Tucson, Arizona 85715, United States

Jonesboro, Arkansas 72401, United States

North Vancouver, British Columbia V7L 2L7, Canada

Richmond, British Columbia V6X1A2, Canada

Glendora, California 91740, United States

Soquel, California 95073, United States

Gilroy, California 95020, United States

Modesto, California 95355, United States

Burbank, California 91505, United States

Fountain Valley, California 92708, United States

Pomona, California 91767, United States

Santa Rosa, California 95405, United States

Montebello, California 90640, United States

Campbell, California 95008, United States

Sacramento, California 95816, United States

Vista, California 92083, United States

Poway, California 92064, United States

San Diego, California 92123, United States

Lakewood, Colorado 80215, United States

Norwalk, Connecticut 06851, United States

Washington, District of Columbia 20010, United States

Zephyrhills, Florida 33542, United States

Miami Shores, Florida 33138, United States

New Port Richey, Florida 34652, United States

Lake Worth, Florida 33461, United States

Sarasota, Florida 34239, United States

Fort Lauderdale, Florida 33305, United States

Jacksonville, Florida 32209, United States

Jacksonville, Florida 32224, United States

Plantation, Florida 33324, United States

Boca Raton, Florida 33428, United States

Hollywood, Florida 33021, United States

Roswell, Georgia 30076, United States

Columbus, Georgia 31902, United States

Thomasville, Georgia 31792, United States

Atlanta, Georgia 30309-1710, United States

Coeur d'Alene, Idaho 83814, United States

Springfield, Illinois 62702, United States

Skokie, Illinois 60076, United States

Urbana, Illinois 61801, United States

Centralia, Illinois 62801, United States

Skokie, Illinois 60077, United States

Munster, Indiana 46321, United States

South Bend, Indiana 46601, United States

Lexington, Kentucky 40504, United States

Bethesda, Maryland 20817, United States

Towson, Maryland 21204, United States

Baltimore, Maryland 21237, United States

Frederick, Maryland 21701, United States

Baltimore, Maryland 21231, United States

Baltimore, Maryland 21201, United States

Boston, Massachusetts 02135, United States

Boston, Massachusetts 02118, United States

Flint, Michigan 48503, United States

Grand Rapids, Michigan 49546, United States

Detroit, Michigan 48202, United States

Grand Rapids, Michigan 49503, United States

Ann Arbor, Michigan 48109, United States

Minneapolis, Minnesota 55455, United States

Hattiesburg, Mississippi 39401, United States

Rolla, Missouri 65401, United States

Great Falls, Montana 59406, United States

Omaha, Nebraska 68198, United States

Carson City, Nevada 89703, United States

Lebanon, New Hampshire 03756, United States

Belleville, New Jersey 07109, United States

Somerset, New Jersey 08873, United States

Albuquerque, New Mexico 87109, United States

Staten Island, New York 10305, United States

New York, New York 10032, United States

East Syracuse, New York 13057, United States

Nyack, New York 10960, United States

Binghamton, New York 13905, United States

Gastonia, North Carolina 28054, United States

Wilmington, North Carolina 28401, United States

Winston-Salem, North Carolina 27103, United States

Charlotte, North Carolina 28203, United States

Bismark, North Dakota 58504, United States

Halifax, Nova Scotia B3H 1V7, Canada

Columbus, Ohio 43235, United States

Canton, Ohio 44718, United States

Cleveland, Ohio 44106-5055, United States

Cincinnati, Ohio 45238, United States

Mayfield Heights, Ohio 44124, United States

Columbus, Ohio 43215, United States

Cincinnati, Ohio 45219, United States

Canton, Ohio 44710, United States

Cleveland, Ohio 44195, United States

Toronto, Ontario M5G 1X5, Canada

Toronto, Ontario M5G 2m9, Canada

Toronto, Ontario M4C-3E7, Canada

Newmarket, Ontario L3Y 2P9, Canada

Toronto, Ontario M4N 3N5, Canada

Hamilton, Ontario L8V 5C2, Canada

Barrie, Ontario L4M 6M2, Canada

Corvallis, Oregon 97330, United States

Portland, Oregon 97213, United States

Philadelphia, Pennsylvania 19106, United States

Langhorne, Pennsylvania 19047, United States

Pittsburgh, Pennsylvania 15213, United States

Hershey, Pennsylvania 17033, United States

Harrisburg, Pennsylvania 17110, United States

Levis, Quebec G1V3Z1, Canada

Quebec City, Quebec G1R2J6, Canada

Fleurimont, Quebec J1H 5N4, Canada

Chicoutimi, Quebec G7H 5H6, Canada

Pointe Claire, Quebec H9R4S3, Canada

Saskatoon, Saskatchewan S7N4H4, Canada

Charleston, South Carolina 29425, United States

Columbia, South Carolina 29169, United States

Chattanooga, Tennessee 37404, United States

Nashville, Tennessee 37203, United States

Nashville, Tennessee 37205, United States

Arlington, Texas 76012, United States

Dallas, Texas 75230, United States

Fort Worth, Texas 76104, United States

Tyler, Texas 75701, United States

Corpus Christi, Texas 78412, United States

Irving, Texas 75038, United States

Logan, Utah 84341, United States

Ogden, Utah 84403, United States

Richmond, Virginia 23294, United States

Woodbridge, Virginia 22191, United States

Arlington, Virginia 22205-3637, United States

Seattle, Washington 98101, United States

Morgantown, West Virginia 26505, United States

Starting date: May 2004
Last updated: October 5, 2006