Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

January 4, 2022

Study Completion Date

January 4, 2022

Conditions
Metastatic Breast CancerBreast Carcinoma
Interventions
DRUG

LEE-011

600 mg capsule (3x 200 mg capsules)

DRUG

Fulvestrant

500 mg injection

DRUG

Placebo

600 mg capsule (3x 200 mg capsules)

Trial Locations (13)

10016

NYU Langone Medical Center, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medical Center, New York

10461

Albert Einstein University / Montefiore Medical Center, The Bronx

11042

Northwell Health/Monter Cancer Center, Lake Success

11794

Stony Brook Cancer Center, Stony Brook

30342

Northside Hospital, Inc., Atlanta

35294

University of Alabama at Birmingham (UAB), Birmingham

37232

Vanderbilt-Ingham Cancer Center, Nashville

60611

Northwestern Medical Hospital, Chicago

66205

The University of Kansas Cancer Center, Westwood

53792-001

University of Wisconsin School of Medicine, Madison

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Melissa K Accordino

OTHER