NCT01919229View on ClinicalTrials.gov

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

PHASE2TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Early Breast Cancer
Interventions
DRUG

LEE011 (ribociclib)

Ribociclib was supplied in 200 mg hard gelatin capsules for oral use.

DRUG

letrozole

Letrozole was supplied in 2.5mg tablets for oral use.

Trial Locations (7)

72703

Highlands Oncology Group SC, Fayetteville

90095

University of California at Los Angeles UCLA SC, Los Angeles

169610

Novartis Investigative Site, Singapore

02114

Massachusetts General Hospital SC-9, Boston

77030-4009

University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8), Houston

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY