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

NCT ID: NCT05599334

Last Updated: 2025-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-05

Study Completion Date

2023-01-30

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.

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Detailed Description

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Eligible patients were selected among those who had received at least one dose of neratinib in the context of the early access program conducted in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. Patients were followed up until the end of the study observation period/study entry date (05 July 2022). As this study was retrospective, the decision to prescribe neratinib was taken prior to and independent of the proposal to select a patient for this study.

Conditions

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Breast Cancer Adjuvant Therapy HER2-positive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeanne Suissa

Role: STUDY_DIRECTOR

Pierre Fabre Médicament

Locations

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Clinique Saint-Luc Bouge

Bouge, , Belgium

Site Status

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

Site Status

Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital

Leuven, , Belgium

Site Status

University Hospital Center Zagreb, Department of Oncology, Breast Unit

Zagreb, , Croatia

Site Status

CHU Brest - Hôpital Morvan

Brest, , France

Site Status

Centre Bourgogne

Lille, , France

Site Status

Hopital Prive La Louviere

Lille, , France

Site Status

Ospedale San Donato- ASL 8 Arezzo

Arezzo, , Italy

Site Status

Ospedale Santa Croce

Fano, , Italy

Site Status

IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola

Napoli, , Italy

Site Status

Azienda Ospedaliero Universitaria di Parma

Parma, , Italy

Site Status

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status

Hospital Quironsalud Barcelona

Barcelona, , Spain

Site Status

Hospital Teknon Barcelona

Barcelona, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Ruber Internacional

Madrid, , Spain

Site Status

Hospital Universitario Clinico San Carlos

Madrid, , Spain

Site Status

Hospital General de Catalunya

Sant Cugat del Vallès, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Instituto Valenciano de Oncología IVO, Servicio de Oncología Médica C/ Beltran Baguena

Valencia, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital LLuís Alcanyís de Xàtiva

Valencia, , Spain

Site Status

Countries

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Belgium Croatia France Italy Spain

References

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Krizic 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 Oct 29. doi: 10.1007/s40487-025-00392-w. Online ahead of print.

Reference Type DERIVED
PMID: 41160302 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NIS12501

Identifier Type: -

Identifier Source: org_study_id

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