NCT00062751

Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

A Phase 2 Randomized Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral Temsirolimus (CCI-779), Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Letrozole / Temsirolimus (CCI-779)	Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily
DRUG	Letrozole / Temsirolimus (CCI-779)	Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks
DRUG	Letrozole	Letrozole 2.5 mg daily

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-04-01
• Completion: 2009-10-01
• First posted: 2003-06-13
• Last updated: 2011-04-15
• Results posted: 2010-11-25