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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT04595435
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent and HIPAA authorization
* T1 tumor (less than or equal to 20mm in greatest diameter)
* Unifocal
* Histological Grade 1 or 2
* Node Negative
* ER +ve
* HER-2 -ve
Exclusion Criteria:
* Previous radiation therapy to the involved breast other than IORT within 6 months
* High grade tumors (Histologic grade 3)
* Her-2 Positive
* Lymphovascular invasion
* Metastatic disease
* close proximity to or involvement of skin
* Multifocal cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
55 Years
Study:
NCT04595435
Study Brief:
Protocol Section:
NCT04595435