Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)
Novartis Pharmaceuticals
1,400 participants
Feb 28, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Eligibility
Plain Language Summary
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Interventions
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Letrozole 2.5 mg orally once daily continuously
Anastrozole 1 mg orally once daily continuously.
Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used
Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used
Exemestane 25 mg once daily continuously
Locations(205)
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NCT05827081