RecruitingNCT06797531

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

177 participants

Start Date

Aug 27, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This real-world study (not an experiment — it observes what happens in routine clinical practice) tracks the effectiveness and safety of ribociclib, a drug used alongside hormone therapy, in Saudi Arabian patients with hormone receptor-positive, HER2-negative early-stage breast cancer after surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with hormone receptor-positive (estrogen and/or progesterone receptor positive), HER2-negative early-stage breast cancer - Your cancer is stage IIA (a subset), IIB, or stage III - You are currently receiving ribociclib in combination with hormone therapy (adjuvant endocrine therapy) as part of your treatment plan, started within the past 6 months **You may NOT be eligible if...** - You have already started and stopped ribociclib for reasons other than study exclusion criteria - You have metastatic breast cancer - You have conditions that prevent participation per study guidelines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGribociclib

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

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NCT06797531


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