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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06813456
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Histologic confirmation of breast cancer from 1/1/2022
* Patient treated with systemic and surgical therapy (retrospective phase)
* Signed informed consent
* HER2-0 and/or HER2-low patient, according to IHC and D-DISH/FISH, treatable with systemic and surgical therapy (prospective phase)
Exclusion Criteria:
* Lack of molecular classification on the basis of prognostic-predictive markers ER, PR, Ki67 and HER2 (Luminal A, Luminal B HER2-positive, Luminal B HER2- negative, HER2-positive, Triple negative)
* Prior neoplasms, other than the neoplasm under investigation, arised within the past 5 years
* Missing histological diagnosis of HER2-0 and/or HER2-low breast cancer (prospective phase)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06813456
Study Brief:
Protocol Section:
NCT06813456