Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2029

Conditions
Locoregional RecurrenceHormone Receptor-positive Breast CancerHER2-negative Breast Cancer
Interventions
DRUG

Ribociclib

400 mg orally once daily Days 1-21 (28 day Cycle)

DRUG

Fulvestrant

500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+

DRUG

Anastrozole

1 mg orally once daily

DRUG

Letrozole

2.5 mg orally once daily

DRUG

Exemestane

25 mg orally once daily

Trial Locations (18)

10016

RECRUITING

New York University Clinical Cancer Center, New York

17033

RECRUITING

Penn State Cancer Institute, Hershey

22908

RECRUITING

University of Virginia Health System, Charlottesville

23298

RECRUITING

Virginia Commonwealth University, Richmond

32806

RECRUITING

Orlando Health Cancer Institute, Orlando

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

46845

RECRUITING

Parkview Research Center, Fort Wayne

48109

RECRUITING

University of Michigan Health System, Ann Arbor

49519

TERMINATED

University of Michigan Health-West, Wyoming

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

53705

RECRUITING

University of Wisconsin, Madison

60612

RECRUITING

University of Illinois Cancer Center, Chicago

68198

RECRUITING

University of Nebraska Medical Center, Omaha

85004

RECRUITING

University of Arizona, Phoenix

97213

RECRUITING

Providence Portland Medical Center, Portland

02111

RECRUITING

Tufts Medical Center, Boston

08903

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Oana Danciu

OTHER