Trial Outcomes & Findings for Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer (NCT NCT03121469)

Race and Ethnicity were not collected from any participant.

Assesses the absorbed radiation dose delivered to the tumor bed cavity during surgery. In vivo dosimetry measurements are recorded at two distinct anatomical locations relative to the spherical applicator surface: the south pole and the equator. Data will be reported as the mean value and standard deviation (SD) in Gray (Gy) for each measurement site.

Assesses treatment conformity relative to the prescribed dose of 20 Gray (Gy). A delivered dose is defined as compliant if it reaches at least 80% of the prescription (i.e., $\\ge$ 16 Gy). In vivo measurements are evaluated independently at two locations (south pole and equator). Data will be reported as the number (and percentage) of participants achieving this 16 Gy compliance threshold at each site.

Assesses skin tolerance by measuring the absorbed radiation dose delivered to the skin surface during the procedure. In vivo dosimetry measurements are recorded via two separate skin dosimeters. Data will be reported as the mean value and standard deviation (SD) in Gray (Gy) for each dosimeter site to evaluate exposure levels.

Evaluates compliance with safety protocols for skin tolerance. The maximum acceptable skin dose is set at 6 Gray (Gy). A measurement is defined as compliant if the delivered dose does not exceed this safety threshold ($\\le$ 6 Gy). Data will report the number (and percentage) of participants achieving this compliance status at each of the two skin dosimeter sites.

Evaluates the probability of local relapse-free survival at 5 years using the Kaplan-Meier method. Local relapse-free survival is defined as the time from surgery to the date of first documentation of local recurrence within the treated area or death from any cause. Patients without local recurrence at the time of last follow-up are censored. Data will be reported as the 5-year survival rate percentage along with its 95% confidence interval (95% CI).

The surgeon and the radiation oncologist will define the satisfaction or not about the application by appreciating the good coaptation of the breast tissues to be irradiated after the local excision (tumor area) with the NBA applicator of RPO. Evaluates the quality of the applicator placement as judged by the operating surgeon based on the percentage of the tumor bed covered. Results are classified into 4 categories: Highly Satisfactory (greater than 90% coverage), Satisfactory (greater than 80% to 90% coverage), Moderately Satisfactory (greater than 50% to 80% coverage), and Unsatisfactory (less than or equal to 50% coverage). Data will report the count of participants in each category.