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

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NCT00083993

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Hoover, Alabama, 35216 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, Neoplasm Metastasis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00083993
Pfizer
Terminated
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

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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
Interventional
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.
 
Terminated
1236
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)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00083993
3066A1-303
Not Provided
Not Provided
Not Provided
Not Provided
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

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