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RECRUITING
NCT06797531

RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.

Official title: Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

177

Start Date

2025-08-27

Completion Date

2028-11-30

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

ribociclib

This is an observational study. There is no treatment allocation. The decision to initiate ribociclib will be based solely on clinical judgement.

Locations (2)

Novartis Investigative Site

Riyadh, Saudi Arabia

Novartis Investigative Site

Riyadh, Saudi Arabia