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

Completed

Conditions: Adjuvant Therapy
Breast Cancer
HER2-positive Breast Cancer

Registration Number: NCT05599334

Lead Sponsor: Pierre Fabre Medicament

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 111

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of Age	At baseline	Age will be assessed in years = neratinib initiation date - date of birth
Description of Gender	At baseline	Gender will be described in percentage of Male and Female among patients
Description of BMI	At baseline	BMI will be assessed in kg/m2
Menopausal Status	At baseline	Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
Comorbidities	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	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	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	At initial diagnosis	Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
Primary Tumor Histology	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	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	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (25): Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪
Hasselt, Belgium
Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital
🇧🇪
Leuven, Belgium
University Hospital Center Zagreb, Department of Oncology, Breast Unit
🇭🇷
Zagreb, Croatia
CHU Brest - Hôpital Morvan
🇫🇷
Brest, France
Centre Bourgogne
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Lille, France
Hopital Prive La Louviere
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Lille, France
Ospedale San Donato- ASL 8 Arezzo
🇮🇹
Arezzo, Italy
Ospedale Santa Croce
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Fano, Italy
IRCCS Ospedale Policlinico San Martino
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Genova, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola
🇮🇹
Napoli, Italy
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Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Belgium