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.
Study Type
OBSERVATIONAL
Enrollment
111
Clinique Saint-Luc Bouge
Bouge, Belgium
Description of Age
Age will be assessed in years = neratinib initiation date - date of birth
Time frame: At baseline
Description of Gender
Gender will be described in percentage of Male and Female among patients
Time frame: At baseline
Description of BMI
BMI will be assessed in kg/m2
Time frame: At baseline
Menopausal Status
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: At initial diagnosis
Primary Tumor Location
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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
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
...and 15 more locations
Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At initial diagnosis