NCT01919229

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

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-08-08
• Last updated: 2016-01-01
• Results posted: 2016-01-01

Locations

7 sites across 3 countries: United States, Singapore, Spain