Trial Identifiers
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Scientific Title
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Commercial Sponsor
Hoffmann-La Roche
Summary
Eligible participants will be randomised to receive Giredestrant or a therapy of the physician's choice. Giredestrant will be administered as a 30mg orally, once a day on Days 1-28 of each 28-day cycle for 5-years or until disease recurrence or unacceptable toxicity occurs. The hormone therapy of physician's choice is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane.