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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06797531
Status
Recruiting
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Conditions

  • HR+/HER2- Early Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 27, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
177 participants (estimated)

Arms

  • Arm: Ribocliclib
    HR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment

Primary Outcome Measure

Invasive Breast Cancer-Free Survival (iBCFS) [ Time Frame: 36 months ]

Central Contacts