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Researchers review Real-World use of neratinib in early breast cancer

NCT ID NCT05599334

Knowledge-focused Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study reviewed medical records of 111 adults with early-stage HER2-positive breast cancer who received the drug neratinib after their initial treatment. The goal was to describe their age, gender, health conditions, and tumor details. This was an observational study, meaning no new treatment was given—just information was collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

111 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjuvant therapy Breast cancer HER2-positive breast cancer

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Italy

  • CHU Brest - Hôpital Morvan

    Brest, France

  • Centre Bourgogne

    Lille, France

  • Clinique Saint-Luc Bouge

    Bouge, Belgium

  • Complejo Hospitalario de Jaén

    Jaén, Spain

  • Hopital Prive La Louviere

    Lille, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital General Universitario de Valencia

    Valencia, Spain

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Spain

  • Hospital LLuís Alcanyís de Xàtiva

    Valencia, Spain

  • Hospital Quironsalud Barcelona

    Barcelona, Spain

  • Hospital Ruber Internacional

    Madrid, Spain

  • Hospital Teknon Barcelona

    Barcelona, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • IRCCS Ospedale Policlinico San Martino

    Genova, Italy

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

    Valencia, 46009, Spain

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

    Naples, 80131, Italy

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Belgium

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

    Leuven, 3000, Belgium

  • Ospedale San Donato- ASL 8 Arezzo

    Arezzo, Italy

  • Ospedale Santa Croce

    Fano, Italy

  • University Hospital Center Zagreb, Department of Oncology, Breast Unit

    Zagreb, 10000, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.