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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT06928818
Eligibility Criteria:
Inclusion Criteria:
* HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
* Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
* Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression
Exclusion Criteria:
* Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
* Has been previously treated with T-DM1 for advanced breast cancer
* Has been previously treated with 4 or more lines of therapy for advanced breast cancer
* Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06928818
Study Brief:
Protocol Section:
NCT06928818