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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT06243432
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 yo
* Histological diagnosis of HR+/HER2- advanced breast cancer
* Immunohistochemical HER2 negative evaluation (0, 1+ or 2+ FISH-)
* Immunohistochemical expression levels of estrogen and progesterone receptors
* First line CDK4/6 inhibitor plus endocrine therapy stared up to 12/31/2020
* Signing of informed consent approved by local Ethic Committee
Exclusion Criteria:
* Absence of clinical and pathological data that would compromise the definition of the study endpoints
* HER2 positive (ICH 2+ and FISH positive or HER2 3 +) or triple negative disease
* Previous chemotherapy for treatment of metastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06243432
Study Brief:
Protocol Section:
NCT06243432