NCT05591547

Evaluating the Safety and Efficacy of a Novel Accelerated Partial Breast Irradiation Regimen

SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for PatIents with Favorable Risk BreaSt CancEr

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Sanford Health · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Detailed description

This is a prospective observational cohort study in breast cancer participants. The purpose of this study is to report physician-assessed cosmetic outcomes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	IMRT/VMAT-Based Accelerated Partial Breast Irradiation	The lumpectomy bed will receive a total of 26 Gy in 5 fractions, with 1 fraction delivered per day. Ideally, the course of radiation therapy would be completed over 5 consecutive treatment days. Treatment must begin within 12 weeks of lumpectomy or re-excision of surgical margins and must be completed within 10 calendar days.

Timeline

• Start date: 2022-03-30
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-10-24
• Last updated: 2025-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study