376
Participants
Start Date
June 11, 2019
Primary Completion Date
June 11, 2021
Study Completion Date
August 30, 2024
Ribociclib
Ribociclib (at a dosage of 400 mg or 600 mg) QD orally taken on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (days 22 to 28). Ribociclib was supplied as 200 mg tablets as individual patient supply packaged bottles.
Anastrozole
Anastrozole 1 mg tablets for oral use QD continuously
Letrozole
Letrozole 2.5 mg tablets for oral use QD continuously
Goserelin
Goserelin 3.6 mg subcutaneously once every 4 weeks (pre-menopausal women only)
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY