Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05491057
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05491057
Study Brief:
Protocol Section:
NCT05491057