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

Recruiting

• 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

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study Start: 2022-07-08
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of BMI	At baseline	BMI will be assessed in kg/m2
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)
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
Pathologic stage (AJCC classification) of Breast Cancer	At initial diagnosis	Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C
Primary tumor location	At initial diagnosis	Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
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
Comorbidities	At baseline	Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity
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
Menopausal status	At baseline	Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
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

Trial Locations

Locations (1)

Clinique Saint-Luc Bouge; 🇧🇪 Bouge, Belgium