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Brief Title: BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)
Official Title: BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)
Study ID: NCT01961531
Brief 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
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
UCSD Moores Cancer Center, La Jolla, California, United States
Watson Cancer Center, Lakeland, Florida, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Name: Jaroslaw Hepel, M.D.
Affiliation: Brown University
Role: PRINCIPAL_INVESTIGATOR