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

NCT05599334 | Completed Results

• 1 other identifier: NIS12501
• Study Type: observational
• Target: 111
• Locations: 5 countries
• Sites: 25

Brief 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.

Conditions

Breast Cancer; Adjuvant Therapy; HER2-positive Breast Cancer

Keywords

HER2-positive Breast Cancer; Adjuvant therapy

Outcome Measures

Primary Outcomes (11)

• 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. 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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• Iqvia Pty Ltd: collaborator

Study Sites (25)

Clinique Saint-Luc Bouge

Bouge, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

Location

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

Leuven, 3000, Belgium

Location

University Hospital Center Zagreb, Department of Oncology, Breast Unit

Zagreb, 10000, Croatia

Location

CHU Brest - Hôpital Morvan

Brest, France

Location

Centre Bourgogne

Lille, France

Location

Hopital Prive La Louviere

Lille, France

Location

Ospedale San Donato- ASL 8 Arezzo

Arezzo, Italy

Location

Ospedale Santa Croce

Fano, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Location

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

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, Italy

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, Spain

Location

Hospital Teknon Barcelona

Barcelona, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Hospital Ruber Internacional

Madrid, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, Spain

Location

Hospital General de Catalunya

Sant Cugat del Vallès, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

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

Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital LLuís Alcanyís de Xàtiva

Valencia, Spain

Location

Related Publications (1)

• 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 Dec;13(4):1205-1224. doi: 10.1007/s40487-025-00392-w. Epub 2025 Oct 29.

  PMID: 41160302 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Director (Jeanne Suissa)
• Organization: Pierre Fabre Médicament

jeanne.suissa@pierre-fabre.com

+33149108269

Study Officials

• Jeanne Suissa

  Pierre Fabre Médicament

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: October 31, 2022
• Study Start: July 5, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Locations

BE (3); CR (1); ES (13); FR (3); IT (5)