Clinical trial · Observational
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)
NCT05599334CI-TRIAL-00096307NEARcompletedResults postedClinicalTrials.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 purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (11)
- measure
- Description of Age
- timeFrame
- At baseline
- description
- Age will be assessed in years = neratinib initiation date - date of birth
- measure
- Description of Gender
- timeFrame
- At baseline
- description
- Gender will be described in percentage of Male and Female among patients
- measure
- Description of BMI
- timeFrame
- At baseline
- description
- BMI will be assessed in kg/m2
- measure
- Menopausal Status
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients will be eligible for inclusion if they fulfill all of the following criteria: * Age ≥ 18 years at neratinib treatment initiation * Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020 * Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition. Exclusion Criteria: * N/A
References
Publications (1)
- DERIVEDKrizic M, Silovski T, Hoste G, Dedic Plavetic N, Romano O, Gonzalez Farre X, Cano Jimenez A, Guerrero Zotano A, Suissa J, Beghdad F, Dialla O, Zivanov M, De Laurentiis M. A Retrospective Observational Study of Extended Adjuvant Neratinib for HER2-Positive Early-Stage Breast Cancer in a European Early Access Program. Oncol Ther. 2025 Dec;13(4):1205-1224. doi: 10.1007/s40487-025-00392-w. Epub 2025 Oct 29. PMID 41160302