Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00083993|
Recruitment Status : Terminated
First Posted : June 8, 2004
Last Update Posted : November 8, 2011
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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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Neoplasm Metastasis||Drug: Temsirolimus (CCI-779) for 34 months Drug: Letrozole for 34 months||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1236 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||May 2004|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
- To determine overall progression free survival.
- To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083993
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Other Study ID Numbers:||
|First Posted:||June 8, 2004 Key Record Dates|
|Last Update Posted:||November 8, 2011|
|Last Verified:||November 2011|
Neoplasms by Site
Steroid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs