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

Pierre Fabre

Status: Completed

Conditions: Breast Cancer; HER2-positive Breast Cancer; Adjuvant Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05599334

NIS12501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design