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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT04088435
Eligibility Criteria:
Inclusion Criteria:
* T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery
* Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node
* Tumors 2.5 cm or less in size (clinical preoperative staging)
* Estrogen receptor positive tumors (≥10%)
* Her2 negative/not over-expressed
* Patients 50 years of age or greater
Exclusion Criteria:
* Prior malignancy not in remission
* Active collagen vascular disease requiring active cytotoxic or immunotherapy
* Psychiatric or mental condition which would preclude informed consent
* Prior thoracic radiation which overlaps with IORT field
* Pregnant patients
* Patients \<50 years
* Risk of positive sentinel lymph node \>20% based on nomogram estimates
* Known lymph node metastases (i.e. clinically node positive)
* Patients with invasive lobular carcinoma
* Patients with pure DCIS
* Known multifocal or multicentric tumor
* Patients requiring neoadjuvant chemotherapy
* Patients requiring or choosing mastectomy with or without reconstruction
* Technical contraindications to IORT dose delivery including skin to balloon distance \<7 mm
* Medical contraindication to IORT, radiation or breast conservation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04088435
Study Brief:
Protocol Section:
NCT04088435