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Active Not Recruiting NCT04595435

IORT-Breast at Medical Center Navicent Health

Conditions: Breast Cancer Female, Early-stage Breast Cancer

Sex: Female
Ages: 55 Years – N/A
Healthy volunteers: No
Enrollment: 94
Sponsor: Wake Forest University Health Sciences

Location: Medical Center, Navicent Health Macon Georgia

Summary

Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04595435). StuddyBuddy aggregates publicly available trial information.