NCT05827081

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study consists of Screening, Treatment, and Follow-up periods. * Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment. * Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study \[EOS\]), whichever occurs first.

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
DRUG	Letrozole	Letrozole 2.5 mg orally once daily continuously
DRUG	Ansastrozole	Anastrozole 1 mg orally once daily continuously.
DRUG	Goserelin	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
DRUG	Leuprolide	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
DRUG	Exemestane	Exemestane 25 mg once daily continuously

Timeline

• Start date: 2024-02-28
• Primary completion: 2029-09-07
• Completion: 2030-09-20
• First posted: 2023-04-24
• Last updated: 2026-04-14

Locations

199 sites across 16 countries: United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, India, Israel, Mexico, Portugal, Puerto Rico, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study