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

Breast Cancer Clinical Trial

— NEAR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599334
• Other study ID #: NIS12501
• Status: Recruiting
• Start date: July 8, 2022
• Est. completion date: February 2023

Study information

• Verified date: October 2022
• Source: Pierre Fabre Medicament
• Contact: Marta ZIVANOV, PhD
• Phone: +33 6 75 92 57 72
• Email: marta.zivanov[@]pierre-fabre.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Therapy
• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Locations

Country	Name	City	State
Belgium	Clinique Saint-Luc Bouge	Bouge

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Medicament	Iqvia Pty Ltd

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of age	Age will be assessed in years = neratinib initiation date - date of birth	At baseline
Primary	Description of Gender	Gender will be described in percentage of Male and Female among patients	At baseline
Primary	Description of BMI	BMI will be assessed in kg/m2	At baseline
Primary	Menopausal status	Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea	At baseline
Primary	Comorbidities	Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity	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)	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	At initial diagnosis
Primary	Primary tumor location	Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer	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	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	At initial diagnosis
Primary	Pathologic stage (AJCC classification) of Breast Cancer	Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C	At initial diagnosis