ClinicaliQ Trial Snapshot
- Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters. — Recruiting • Oncology • NCT07243002.
- What is being tested: A real-world evaluation of ribociclib (CDK4/6 inhibitor) effectiveness, persistence, safety profile, treatment patterns, and patient-reported outcomes including adherence, satisfaction, and quality of life in hormone receptor-positive/HER2-negative early breast cancer patients.
- Patient eligibility overview: The study includes HR+/HER2-negative patients with stage II and III early breast cancer (eBC) receiving ribociclib in routine clinical practice, capturing data from early adopters across real-world treatment settings.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.