140
Participants
Start Date
July 9, 2025
Primary Completion Date
September 30, 2030
Study Completion Date
September 30, 2030
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).
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.
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.
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.
Adjuvant chemotherapy
Adjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.
RECRUITING
Yale University, New Haven
Collaborators (2)
Novartis
INDUSTRY
Breast Cancer Research Foundation
OTHER
Yale University
OTHER