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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00083993
Recruitment Status : Terminated
First Posted : June 8, 2004
Last Update Posted : November 8, 2011
Information provided by:

June 4, 2004
June 8, 2004
November 8, 2011
May 2004
October 2006   (Final data collection date for primary outcome measure)
To determine overall progression free survival.
Not Provided
Complete list of historical versions of study NCT00083993 on ClinicalTrials.gov Archive Site
To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.
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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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Drug: Temsirolimus (CCI-779) for 34 months
  • Drug: Letrozole for 34 months
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2006
October 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP