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

November 7, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
      • Richmond, British Columbia, Canada, V6X1A2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
      • Hamilton, Ontario, Canada, L8V 5C2
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M4C-3E7
      • Toronto, Ontario, Canada, M4N 3N5
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Fleurimont, Quebec, Canada, J1H 5N4
      • Levis, Quebec, Canada, G1V3Z1
      • Pointe Claire, Quebec, Canada, H9R4S3
      • Quebec City, Quebec, Canada, G1R2J6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N4H4
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Tucson, Arizona, United States, 85715
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
    • California
      • Burbank, California, United States, 91505
      • Campbell, California, United States, 95008
      • Fountain Valley, California, United States, 92708
      • Gilroy, California, United States, 95020
      • Glendora, California, United States, 91740
      • Modesto, California, United States, 95355
      • Montebello, California, United States, 90640
      • Pomona, California, United States, 91767
      • Poway, California, United States, 92064
      • Sacramento, California, United States, 95816
      • San Diego, California, United States, 92123
      • Santa Rosa, California, United States, 95405
      • Soquel, California, United States, 95073
      • Vista, California, United States, 92083
    • Colorado
      • Lakewood, Colorado, United States, 80215
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Boca Raton, Florida, United States, 33428
      • Fort Lauderdale, Florida, United States, 33305
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32209
      • Jacksonville, Florida, United States, 32224
      • Lake Worth, Florida, United States, 33461
      • Miami Shores, Florida, United States, 33138
      • New Port Richey, Florida, United States, 34652
      • Plantation, Florida, United States, 33324
      • Sarasota, Florida, United States, 34239
      • Zephyrhills, Florida, United States, 33542
    • Georgia
      • Atlanta, Georgia, United States, 30309-1710
      • Columbus, Georgia, United States, 31902
      • Roswell, Georgia, United States, 30076
      • Thomasville, Georgia, United States, 31792
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
    • Illinois
      • Centralia, Illinois, United States, 62801
      • Skokie, Illinois, United States, 60076
      • Skokie, Illinois, United States, 60077
      • Springfield, Illinois, United States, 62702
      • Urbana, Illinois, United States, 61801
    • Indiana
      • Munster, Indiana, United States, 46321
      • South Bend, Indiana, United States, 46601
    • Kentucky
      • Lexington, Kentucky, United States, 40504
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21237
      • Baltimore, Maryland, United States, 21231
      • Bethesda, Maryland, United States, 20817
      • Frederick, Maryland, United States, 21701
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48202
      • Flint, Michigan, United States, 48503
      • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids, Michigan, United States, 49546
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
    • Missouri
      • Rolla, Missouri, United States, 65401
    • Montana
      • Great Falls, Montana, United States, 59406
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • Nevada
      • Carson City, Nevada, United States, 89703
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Belleville, New Jersey, United States, 07109
      • Somerset, New Jersey, United States, 08873
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • Binghamton, New York, United States, 13905
      • East Syracuse, New York, United States, 13057
      • New York, New York, United States, 10032
      • Nyack, New York, United States, 10960
      • Staten Island, New York, United States, 10305
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Gastonia, North Carolina, United States, 28054
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Bismark, North Dakota, United States, 58504
    • Ohio
      • Canton, Ohio, United States, 44718
      • Canton, Ohio, United States, 44710
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45238
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106-5055
      • Columbus, Ohio, United States, 43215
      • Columbus, Ohio, United States, 43235
      • Mayfield Heights, Ohio, United States, 44124
    • Oregon
      • Corvallis, Oregon, United States, 97330
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
      • Hershey, Pennsylvania, United States, 17033
      • Langhorne, Pennsylvania, United States, 19047
      • Philadelphia, Pennsylvania, United States, 19106
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Columbia, South Carolina, United States, 29169
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Nashville, Tennessee, United States, 37203
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Arlington, Texas, United States, 76012
      • Corpus Christi, Texas, United States, 78412
      • Dallas, Texas, United States, 75230
      • Fort Worth, Texas, United States, 76104
      • Irving, Texas, United States, 75038
      • Tyler, Texas, United States, 75701
    • Utah
      • Logan, Utah, United States, 84341
      • Ogden, Utah, United States, 84403
    • Virginia
      • Arlington, Virginia, United States, 22205-3637
      • Richmond, Virginia, United States, 23294
      • Woodbridge, Virginia, United States, 22191
    • Washington
      • Seattle, Washington, United States, 98101
    • West Virginia
      • Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
To determine overall progression free survival.

Secondary Outcome Measures

Outcome Measure
To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

June 4, 2004

First Submitted That Met QC Criteria

June 7, 2004

First Posted (Estimate)

June 8, 2004

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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