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

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.

The study aims to recruit 177 patients who have been newly receiving ribociclib for up to 6 months prior to enrollment date, as per the locally approved label to which the physician has made an independent decision to prescribe ribociclib. Patients will be enrolled over a recruitment window of 9 months and will be followed up for 36 months to assess the study outcomes. It is planned to capture data at the following timepoints (+/- 1 month): Baseline, 3, 6, 12, 24, and 36 months. This is in line with the frequency of routine follow-up visits, per standard of care.

Data will be collected from patients' electronic medical records in the selected sites. The planned number of sites is 6, to be selected based on feasibility reports, considering the patient pool and research capabilities.

Participating sites' investigators will review all the available clinical files of patients whose ribociclib treatment decision has been made by their treating physician and will invite those who fulfill the eligibility criteria to participate in the study. Data will be entered into an electronic case report form (eCRF). All patients' data will remain anonymized, fulfilling the requirements of data protection. Data collected will include information on previous treatments received, disease history, and current treatment patterns and outcomes.

Participation in the study is not intended to change the routine treatment patients receive as determined by their treating physicians; all therapeutic decisions, as well as the type and timing of disease monitoring, will be at the discretion of the treating physician.

• Invasive disease free survival (iDFS) [Срок оценки: Up to 36 months]
• Distant disease free survival (DDFS) [Срок оценки: Up to 36 months]
• Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: 36 months]
• Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30 [Срок оценки: 36 months]
• Demographics - Age [Срок оценки: Baseline]
• Demographics - Gender, race, region [Срок оценки: Baseline]
• Clinical characteristics - menopausal status [Срок оценки: Baseline up to 36 months]
• Clinical characteristics - anatomical stage [Срок оценки: Baseline up to 36 months]
• Clinical characteristics - pre-index chemotherapy and concomitant medication [Срок оценки: Baseline up to 36 months]
• Clinical characteristics - medical history [Срок оценки: Baseline up to 36 months]