Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters: A Hybrid Study With Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review.
This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.
• Males or females.
• Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
• Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
• Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
• Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
• Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:
‣ Tested positive for estrogen receptor (ER+), or
⁃ Tested positive for progesterone receptor (PR+), or
⁃ Tested positive for both.
• Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.