Conditions: Early Breast Cancer
Keywords: HR-positive HER2-negative Breast cancer LEE011 Letrozole CDK CDK4 CDK6 CDK4/6 Pharmacodynamics Pre-surgical Postmenopausal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.

Detailed description:
This randomized pre-surgical pharmacodynamics study will assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer.

Arms:
arm 1: Letrozole 2.5 mg alone once daily arm 2: Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily. arm 3: Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.

Interventions: intervention 1: LEE011 (ribociclib) intervention 2: letrozole
Intervention descriptions: intervention 1: Ribociclib was supplied in 200 mg hard gelatin capsules for oral use. intervention 2: Letrozole was supplied in 2.5mg tablets for oral use.

Protocol document: