Clinical trial · Observational
A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib
Real-world Effectiveness and Safety in HR+/HER2- Advanced or Metastatic BC Patients Treated With Ribociclib or Alpelisib: A European Non-interventional Retrospective Study (REASSURE)
- 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 study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.
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 |
|---|---|---|---|
| Hormone Receptor Positive HER-2 Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Institut de Cancérologie de l'Ouest (ICO) Cohort
- description
- Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's oncology evidence network (OEN), ICO, and initiated treatment with ribociclib or alpelisib.
- label
- L'Institut Curie (Curie) Cohort
- description
- Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, Curie, and initiated treatment with ribociclib or alpelisib.
- label
- Instituto Português de Oncologia do Porto (IPO-Porto) Cohort
- description
- Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, IPO-Porto, and initiated treatment with ribociclib or alpelisib.
- label
- Czech Republic Cohort
- description
- Patients with HR+/HER2- advanced or metastatic BC who were registered in Czech Republic local sites or clinics proposed by Novartis affiliates and initiated treatment with ribociclib or alpelisib.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physician took the decision to initiate treatment with ribociclib or alpelisib. * Patients with at least one prescription for ribociclib or alpelisib during the index period (01 January 2018 to 30 September 2021). Exclusion criteria: * Patients who were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and other); patients who were participating in other investigator-initiated research or non-interventional study (NIS) could be included as long as their standard of care was not altered by the study. * Patients on active treatment for malignancies other than HR+/HER2- aBC/mBC at the time of index. * IPO-Porto cohort only: * Patients who had participated or were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and others). * Patients who underwent part of the treatment for locally advanced/metastatic not amenable to surgery HR+/HER2- BC outside the center.
References
Publications (0)
Data not yet available