Breast CancerNEARNCT05599334
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
An observational study of Breast Cancer and Adjuvant Therapy, run by Pierre Fabre Medicament at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- How many people
- 111 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 5 Jul 2022to 30 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
Spain13 sites
Hospital Clinic Barcelona
Barcelona
Hospital Quironsalud Barcelona
Barcelona
Hospital Teknon Barcelona
Barcelona
Complejo Hospitalario de Jaén
Jaén
Hospital Universitari Arnau de Vilanova
Lleida
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Ruber Internacional
Madrid
Hospital Universitario Clinico San Carlos
Madrid
Hospital General de Catalunya
Sant Cugat del Vallès
Hospital Universitario Marqués de Valdecilla
Santander
Instituto Valenciano de Oncología IVO, Servicio de Oncología Médica C/ Beltran Baguena
Valencia, 46009
Hospital General Universitario de Valencia
Valencia
Hospital LLuís Alcanyís de Xàtiva
Valencia
Italy5 sites
Ospedale San Donato- ASL 8 Arezzo
Arezzo
Ospedale Santa Croce
Fano
IRCCS Ospedale Policlinico San Martino
Genova
Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola
Naples, 80131
Azienda Ospedaliero Universitaria di Parma
Parma
Belgium3 sites
Clinique Saint-Luc Bouge
Bouge
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital
Leuven, 3000
France3 sites
CHU Brest - Hôpital Morvan
Brest
Centre Bourgogne
Lille
Hopital Prive La Louviere
Lille
Croatia1 site
University Hospital Center Zagreb, Department of Oncology, Breast Unit
Zagreb, 10000
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- Keywords
- HER2-positive Breast Cancer, Adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of Age
Age will be assessed in years = neratinib initiation date - date of birth
Measured: At baseline
Description of Gender
Gender will be described in percentage of Male and Female among patients
Measured: At baseline
Description of BMI
BMI will be assessed in kg/m2
Measured: At baseline
Menopausal Status
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
Measured: 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)
Measured: 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)
Measured: 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
Measured: At initial diagnosis
Primary Tumor Location
Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
Measured: 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
Measured: 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
Measured: 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
Measured: At initial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start5 Jul 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Jeanne Suissa, Study director, Pierre Fabre Médicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599334
- Sponsor's protocol ID
- NIS12501
- Acronym
- NEAR
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2022
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41160302
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05599334
- Acronym / sponsor ID
- NEAR / NIS12501
- Conditions
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- Keywords
- HER2-positive Breast Cancer, Adjuvant therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients will be eligible for inclusion if they fulfill all of the following criteria:
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of Age
Time frame: At baseline
Age will be assessed in years = neratinib initiation date - date of birth
Description of Gender
Time frame: At baseline
Gender will be described in percentage of Male and Female among patients
Description of BMI
Time frame: At baseline
BMI will be assessed in kg/m2
Menopausal Status
Time frame: At baseline
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
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)
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)
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41160302Krizic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Suissa study director
Pierre Fabre Médicament
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Adjuvant Therapy, run by Pierre Fabre Medicament at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain, Italy, Belgium, France, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of Age (time frame: At baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05599334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.