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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT05173103
Eligibility Criteria:
Inclusion Criteria:
* age\> 18 years
* female sex
* Performance Status (ECOG) 0-2;
* hormonal-receptor positive breast cancer (Estrogen and / or Progesterone positive), HER2 negative, with evidence of stage IV / locally advanced inoperable disease
* Radiologically documented progression in 1st line treatment with Hormonal Therapy (Aromatase inhibitor / Fulvestrant) + CDK4-6i (Palbociclib / Ribociclib / Abemaciclib)
* Execution of at least one subsequent therapeutic line chosen by the clinician, with at least one radiological re-evaluation during this treatment by 31 December 2020.
* Radiologically measurable or evaluable lesions
* Written informed consent
Exclusion Criteria:
* age \<18 years
* previous neoplastic pathology, within 5 years of the last active treatment
* Previous chemotherapy treatments, with biological or endocrine therapies for advanced disease, different from first-line therapy with OT + CDK4 / 6i
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05173103
Study Brief:
Protocol Section:
NCT05173103