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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04225858
Eligibility Criteria:
Inclusion Criteria:
* Women, aged ≥ 18 years
* Invasive HER2+ (HR+/-) or TN breast cancer
* Primary tumor (T), clinical stage T1-3
* Neoadjuvant systemic therapy (NST), at least 3 cycles
* Tumor stage assessed with breast MRI before start NST
* Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes)
* MRI after or during NST shows radiologic complete response
* Written and signed informed consent
Exclusion Criteria:
* Primary tumor (T) clinical stage T4
* Patients without ultrasound or FDG-PET/CT pre-NST
* History of breast cancer ipsilateral breast
* Synchronous contralateral breast cancer
* Synchronous M1 disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04225858
Study Brief:
Protocol Section:
NCT04225858