NCT07067437

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: National Institute of Oncology, Hungary · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.

Detailed description

Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy \& Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome. Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely. A phase II multicenter trial is proposed to confirm this hypothesis.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
RADIATION	single-fraction very accelerated partial breast irradiation	Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2032-08-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

22 sites across 9 countries: France, Germany, Hungary, Lithuania, Poland, Portugal, Serbia, Spain, Switzerland