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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT07108595
Eligibility Criteria:
Inclusion Criteria:
1. female patients aged ≥18 years;
2. histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;
3. radiologically confirmed recurrent or metastatic disease;
4. completion of ≥2 cycles of T-DXd therapy;
5. comprehensive medical documentation;
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3;
7. measurable target lesions according to RECIST 1.1
Exclusion Criteria:
1. history of interstitial lung disease
2. incomplete medical records
3. concurrent malignancies;
4. pregnancy or lactation
5. psychiatric disorders compromising treatment adherence
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07108595
Study Brief:
Protocol Section:
NCT07108595