Clinical trial · Observational
Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Ribociclib arm
- description
- Patient treated with ribociclib and Endocrine Therapy (ET) per standard of care
- label
- Abemaciclib arm
- description
- Patient treated with abemaciclib and Endocrine Therapy (ET) per standard of care
Primary outcomes (2)
- measure
- Invasive disease-free survival (iDFS)
- timeFrame
- 36 months
- description
- iDFS is defined as time to first invasive breast cancer recurrence (ipsilateral, contralateral, local/regional, distant), new primary invasive cancer, or death from breast cancer, non-breast cancer or unknown cause.
- measure
- Distant disease-free survival (DDFS)
- timeFrame
- 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date. * Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period. * Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.
References
Publications (0)
Data not yet available