Clinical trial · Observational
A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients
Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in the Real-World Practice of HR+/HER2- Early Breast Cancer (CATTALYST)
NCT07710716CI-TRIAL-00118431CATTALYSTactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) patients. This is a multi-country study using secondary real-world data sources.
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
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cohort A: Contemporaneous Ribociclib-eligible Patients
- description
- Adult HR+/HER2- eBC patients who have undergone surgical resection of the primary breast tumor and initiated adjuvant ET and meet additional staging criteria including either Stage III, or Stage IIB, or Stage IIA with N1, Stage IIA with N0 and Grade 3, or Stage IIA with N0 and Grade 2 and Ki-67 ≥20% or high genomic risk.
- label
- Cohort B: Ribociclib-treated Patients
- description
- Adult HR+/HER2- eBC patients who have undergone surgical resection of the primary breast tumor and initiated adjuvant ribociclib in addition to ET.
- label
- Subcohort B1: Ribociclib-treated Subcohort for Landmark Safety Analysis
- description
- Patients in Cohort B who have at least six months of potential follow-up time after ribociclib initiation at the time of the analysis.
Primary outcomes (17)
- measure
- Cohort B and Subcohort B1: Proportion of Patients by Baseline Demographics and Clinical Characteristics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Evidence of diagnosis of eBC during the identification period. 2. Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC. 3. Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date. 4. Evidence of HR+ during the study period: 1. have tested positive for estrogen receptor (ER+), or 2. have tested positive for progesterone receptor (PR+), or 3. have tested positive for both. 5. Tested negative for HER2 (HER2-) during the study period. 6. Evidence of surgical resection of the primary breast tumor at any time. 7. Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date. Exclusion criteria: 1. Evidence of another secondary malignancy at any time prior to index diagnosis date. 2. Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date. 3. Patients who participate in an interventional clinical trial at any time prior to or during the study period. 4. Patients with severely incomplete or inconsistent data, precluding validity of results. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.