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

NCT06797531 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • HR+/HER2- Early Breast Cancer

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Saudi Arabia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797531 on ClinicalTrials.gov