N/A
N=111
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
Breast Cancer · Adjuvant Therapy · HER2-positive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05599334 ↗Enrolled (actual)
111
Serious AEs
11.1%
Results posted
Oct 2025
Primary outcome: Primary: Description of Age — 49.2 years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pierre Fabre Medicament
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Description of Age |
49.2 | — |
| PRIMARY Description of Gender |
107; 1 | — |
| PRIMARY Description of BMI |
26.7 | — |
| PRIMARY Menopausal Status |
40; 5; 34; 11; 17; 1 | — |
| PRIMARY Comorbidities |
26 | — |
| PRIMARY HER2 Overexpression/Amplification Testing |
81; 24; 1; 2 | — |
| PRIMARY Hormone Receptor Status |
91; 17; 74; 34 | — |
| PRIMARY Primary Tumor Location |
47; 62 | — |
| PRIMARY Primary Tumor Histology |
56; 3; 43; 6 | — |
| PRIMARY Histological Grade |
5; 34; 54; 15 | — |
| PRIMARY Pathologic Stage (AJCC Classification) of Breast Cancer |
21; 17; 29; 25; 5; 6 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05599334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.