NCT01961531

BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Detailed description

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in women with resected, early stage breast cancer. Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation technology, has the potential to eliminate the disadvantages of the conventional APBI techniques. NIBB facilitates non-invasive partial breast irradiation without the use of catheters or implants. Yet by using breast immobilization and precise image-guidance, it reduces non-target breast tissue within the irradiated field compared with other non-invasive APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI. We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and effective modality to deliver partial breast irradiation. Anticipated advantages of NIBB protocol treatment include: * Convenient treatment schedule * Short course can allow for increased patient access to treatment * Non-invasive approach * Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging * Reduced irradiation of non-target breast tissue * Reduced skin toxicity * No heart or lung radiation exposure * Reduced late skin or breast toxicity * High rate of good or excellent cosmetic outcome * High rate of ipsilateral breast tumor control comparable to other APBI techniques

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Accuboost APBI	28Gy delivered in 5 daily fractions

Timeline

• Start date: 2014-07-24
• Primary completion: 2016-10-26
• Completion: 2021-11-30
• First posted: 2013-10-11
• Last updated: 2022-03-04
• Results posted: 2020-08-25

Locations

3 sites across 1 country: United States