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

NCT01919229 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-01-01

Study results available
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Summary

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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01919229 on ClinicalTrials.gov