A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of age | Age will be assessed in years = neratinib initiation date - date of birth | At baseline | 
| Description of Gender | Gender will be described in percentage of Male and Female among patients | At baseline | 
| Description of BMI | BMI will be assessed in kg/m2 | At baseline | 
| Menopausal status | Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea | At baseline | 
| Comorbidities | Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity | At baseline | 
| HER2 overexpression/amplification testing | HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) | At initial diagnosis | 
| Hormone receptor status | Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative | At initial diagnosis | 
| Primary tumor location | Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer | At initial diagnosis | 
| Primary tumor histology | Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other | At initial diagnosis | 
| Histological grade | Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated | At initial diagnosis | 
| Pathologic stage (AJCC classification) of Breast Cancer | Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C | At initial diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2-positive Breast Cancer, Adjuvant therapy