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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT05945732
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
* Documented HER2-low status (IHC1+, IHC2+/ISH-)
* Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
* Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
* Written and signed Informed Consent to participate in the study
Exclusion Criteria:
* Pregnancy or breastfeeding
* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
No other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05945732
Study Brief:
Protocol Section:
NCT05945732