NCT00083993

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,236 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Temsirolimus (CCI-779) for 34 months
DRUG	Letrozole for 34 months

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2004-06-08
• Last updated: 2011-11-08

Locations

129 sites across 2 countries: United States, Canada