Treatment Patterns of Neratinib in HER2+ EBC in China

Pierre Fabre

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Drug: Neratinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05491057

PF008

Details and patient eligibility

About

This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent approved by the reviewing Ethics Committee (EC).
• Adult patients (≥18 years of age, no upper limit).
• Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.

Exclusion criteria

• Presence of any contraindication with regard to the neratinib treatment.
• Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).

Trial design

500 participants in 1 patient group

Neratinib extended ajuvant treatmeng for 1 year

Treatment:

Drug: Neratinib