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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients will be eligible for inclusion if they fulfill all of the following criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne Suissa | Pierre Fabre Médicament | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint-Luc Bouge | Bouge | Belgium | ||||
| Jessa Ziekenhuis - Campus Virga Jesse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41160302 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neratinib Arm | Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Belgium, Croatia, France, Italy and Spain between 01 August 2017 and 31 December 2020 (the patient identification period). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2021 | May 10, 2024 |
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| 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 |
| Hasselt |
| Belgium |
| Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital | Leuven | 3000 | Belgium |
| University Hospital Center Zagreb, Department of Oncology, Breast Unit | Zagreb | 10000 | Croatia |
| CHU Brest - Hôpital Morvan | Brest | France |
| Centre Bourgogne | Lille | France |
| Hopital Prive La Louviere | Lille | France |
| Ospedale San Donato- ASL 8 Arezzo | Arezzo | Italy |
| Ospedale Santa Croce | Fano | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| Hospital Clinic Barcelona | Barcelona | Spain |
| Hospital Quironsalud Barcelona | Barcelona | Spain |
| Hospital Teknon Barcelona | Barcelona | Spain |
| Complejo Hospitalario de Jaén | Jaén | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain |
| Hospital Ruber Internacional | Madrid | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | Spain |
| Hospital General de Catalunya | Sant Cugat del Vallès | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain |
| Instituto Valenciano de OncologÃa IVO, Servicio de OncologÃa Médica C/ Beltran Baguena | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia | Valencia | Spain |
| Hospital LLuÃs AlcanyÃs de XÃ tiva | Valencia | Spain |
| COMPLETED |
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| NOT COMPLETED |
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The baseline characteristics have been analysed in 108 patients corresponding to the number of patients analysed in the Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Neratinib Arm | Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 111 in the number of enrolled patients and 108 is the number of analysed patients in the FAS | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | 111 in the number of enrolled patients and 108 is the number of analysed patients | Count of Participants | Participants | No |
| ||||||||||||||
| Race (NIH/OMB) | The details of participants by ethnicity was not collected | Count of Participants | Participants | No |
| ||||||||||||||
| Region of Enrollment | The number of enrolled participants is 111 for which the region has been analysed. of note, the region has not been analysed in the 108 analysed participants from the FAS. | The total number of participants of participants is 111 corresponding to the enrolled number of participants on which the disposition by country was analysed, as this was not analysed in the 108 patients corresponding to the FAS. Therefore, the distribution by region has been done out of 111 patients, and not out of 108 patients. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Description of Age | Age will be assessed in years = neratinib initiation date - date of birth | FAS | Posted | Mean | Standard Deviation | years | At baseline |
|
|
| |||||||||||||||||||||||||
| Primary | Description of Gender | Gender will be described in percentage of Male and Female among patients | FAS | Posted | Count of Participants | Participants | At baseline |
|
| |||||||||||||||||||||||||||
| Primary | Description of BMI | BMI will be assessed in kg/m2 | FAS | Posted | Mean | Standard Deviation | Kg/m² | At baseline |
|
| ||||||||||||||||||||||||||
| Primary | Menopausal Status | Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea | FAS | Posted | Number | participants | At baseline |
|
| |||||||||||||||||||||||||||
| Primary | 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) | FAS | Posted | Count of Participants | Participants | At baseline |
|
| |||||||||||||||||||||||||||
| Primary | HER2 Overexpression/Amplification Testing | HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
| |||||||||||||||||||||||||||
| Primary | 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 | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
| |||||||||||||||||||||||||||
| Primary | Primary Tumor Location | Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
| |||||||||||||||||||||||||||
| Primary | Primary Tumor Histology | Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
| |||||||||||||||||||||||||||
| Primary | Histological Grade | Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
| |||||||||||||||||||||||||||
| Primary | 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 | FAS | Posted | Count of Participants | Participants | At initial diagnosis |
|
From the baseline to the study entry date
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neratinib Arm | Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP 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. | 1 | 108 | 12 | 108 | 10 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hepatic enzymze increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Decreased apetite | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Depression | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hyperhydrosis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Skin disorders | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director (Jeanne Suissa) | Pierre Fabre Médicament | +33149108269 | jeanne.suissa@pierre-fabre.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2023 | May 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Spain |
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| Italy |
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| Belgium |
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| France |
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