drugset / Trial / NCT00062751

Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

NCT00062751

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2002-12
Primary completion
2005-04
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 2.5 mg
Subject Temsirolimus Small molecule 10 mg Oral
Subject Temsirolimus Small molecule 30 mg Oral

Indications