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

NCT05591547 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of North Dakota

    collaborator OTHER

  • Sanford Health

    lead OTHER

Principal Investigators

  • Ryan Nowak, MD · Sanford Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591547 on ClinicalTrials.gov