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

September 12, 2025 updated by: Pierre Fabre Medicament

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)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bouge, Belgium
        • Clinique Saint-Luc Bouge
      • Hasselt, Belgium
        • Jessa Ziekenhuis - Campus Virga Jesse
      • Leuven, Belgium, 3000
        • Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb, Department of Oncology, Breast Unit
  • France
      • Brest, France
        • CHU Brest - Hopital Morvan
      • Lille, France
        • Hôpital privé La Louvière
      • Lille, France
        • Centre Bourgogne
  • Italy
      • Arezzo, Italy
        • Ospedale San Donato- ASL 8 Arezzo
      • Fano, Italy
        • Ospedale Santa Croce
      • Genova, Italy
        • IRCCS Ospedale Policlinico San Martino
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma
  • Spain
      • Barcelona, Spain
        • Hospital Clinic Barcelona
      • Barcelona, Spain
        • Hospital Quironsalud Barcelona
      • Barcelona, Spain
        • Hospital Teknon Barcelona
      • Jaén, Spain
        • Complejo Hospitalario de Jaén
      • Lleida, Spain
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain
        • Hospital Ruber Internacional
      • Sant Cugat del Vallès, Spain
        • Hospital General de Catalunya
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología IVO, Servicio de Oncología Médica C/ Beltran Baguena
      • Valencia, Spain
        • Hospital Lluis Alcanyís de Xàtiva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include all patients with early-stage HER2+ breast cancer having received at least one dose of neratinib as an extended adjuvant therapy in the context of the EAP in Europe between August 01, 2017 and December 31, 2020.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of Gender
Time Frame: At baseline
Gender will be described in percentage of Male and Female among patients
At baseline
Description of BMI
Time Frame: At baseline
BMI will be assessed in kg/m2
At baseline
Description of Age
Time Frame: At baseline
Age will be assessed in years = neratinib initiation date - date of birth
At baseline
Menopausal Status
Time Frame: At baseline
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
At baseline
Comorbidities
Time Frame: At baseline
Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)
At baseline
HER2 Overexpression/Amplification Testing
Time Frame: At initial diagnosis
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
Time Frame: At initial diagnosis
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
Time Frame: At initial diagnosis
Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
At initial diagnosis
Primary Tumor Histology
Time Frame: At initial diagnosis
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
Time Frame: At initial diagnosis
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
Time Frame: At initial diagnosis

Higher is the stage worse is the cancer.

Stage is defined as:

1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is < 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is > 2 cm and < 5 cm and not spread to LN.2B: T is > 2 cm and < 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is > 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone
At initial diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Collaborators

IQVIA Pty Ltd

Investigators

  • Study Director: Jeanne Suissa, Pierre Fabre Médicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS12501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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