NCT03437915

BrUOG 351: PRE-OPERATIVE APBI USING NIBB

BrUOG 351: Pre-Operative Accelerated Partial Breast Irradiation (APBI) Using Non-Invasive Image-Guided Breast Brachytherapy (NIBB)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jaroslaw Hepel · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome. In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.

Conditions

• Breast Cancer
• Invasive Breast Cancer
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
RADIATION	NIBB: accuboost	28.5 Gy delivered in 5 daily fractions
PROCEDURE	Partial mastectomy	4-12 weeks post NIBB

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-01-21
• Completion: 2020-01-21
• First posted: 2018-02-19
• Last updated: 2021-03-09