Conditions: Breast Neoplasms
Keywords: breast neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Letrozole / Temsirolimus (CCI-779) intervention 2: Letrozole / Temsirolimus (CCI-779) intervention 3: Letrozole
Intervention descriptions: intervention 1: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily intervention 2: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks intervention 3: Letrozole 2.5 mg daily

Protocol document: