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ACTIVE NOT RECRUITING
NCT05591547
PHASE2

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

Sponsor: Sanford Health

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2022-03-30

Completion Date

2027-06

Last Updated

2025-02-10

Healthy Volunteers

No

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.

Locations (2)

Sanford Health

Worthington, Minnesota, United States

Sanford Health

Sioux Falls, South Dakota, United States