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 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT05289466
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 y.o.
* Histologically proven in situ and invasive ductal or lobular breast recurrence
* Prior history of whole breast/chest wall radiation therapy
* Disease span ≤ 3 cm, unifocal
* No nodal disease (N0)
* No evidence of metastatic disease (M0)
* Time from initial BCT should be ≥ 1 year
* Patients have refused the standard of care of mastectomy
* Skin distance of ≥ 0.8 cm between applicator and skin
Exclusion Criteria:
* Multifocal and/or multicenter recurrence
* N1-3 status: Regional cytological or histologically proven node recurrence
* M1 status: Metastatic disease
* cT4 (Skin or muscle involvement) or Paget's disease of the nipple
* Patients undergoing mastectomy
* Patients undergoing neoadjuvant systemic therapy
* Connective tissue disease or scleroderma, contraindicating radiotherapy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT05289466
Study Brief:
Protocol Section:
NCT05289466