Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

July 9, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
HER2 Negative Breast Cancer
Interventions
DRUG

Ribociclib 400mg

400 mg (2 x 200 mg tablets by mouth) once daily on days 1 to 21 of a 28-day cycle, followed by seven days off ribociclib (Days 22 to 28).

DRUG

Letrozole 2.5mg

Letrozole will be administered as an endocrine therapy. The regimen will differ depending on the demographic of the patient. For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously.

DRUG

Anastrazole 1mg

For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.

DRUG

Goserelin 3.6 MG

For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, concurrently with goserelin 3.6 mg monthly injection.

RADIATION

Adjuvant chemotherapy

Adjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.

Trial Locations (1)

06511

RECRUITING

Yale University, New Haven

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Breast Cancer Research Foundation

OTHER

lead

Yale University

OTHER