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.
Signed and dated Patient Informed Consent Form (PICF) obtained.
The patient is ≥ 18 years-old at the time of PICF signature.
Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
Male or female patients with HER2- BC.
Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
Patients are currently participating in any other clinical trials.
Patients who previously received any other CDK4/6 inhibitor.
Patients who refused to sign informed consent.
HR+/HER2- early breast cancer in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
Cohort
Prospective
ribociclib
DrugThis is an observational study. There is no treatment allocation. The decision to initiate ribociclib will be based solely on clinical judgement.
Invasive Breast Cancer-Free Survival (iBCFS)
iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC. iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
Invasive disease free survival (iDFS)
iDFS is a composite endpoint that contains invasive Ipsilateral Breast Tumor Recurrence (IBTR), loco-regional invasive recurrence, distant recurrence, death from BC, death from non-BC cause, death from unknown cause, invasive contralateral BC and second primary invasive cancer (non-breast) in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB//III EBC.
Distant disease free survival (DDFS)
DDFS defined as distant recurrence, death from BC, death from non-BC cause, death from unknown cause and second primary invasive cancer (non-breast) in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency and severity of AEs and SAEs including laboratory findings, AST/ALT elevations and ECG abnormalities qualifying and reported as AEs.
Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (EORTC QLQ-C30) incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
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