To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
28Gy delivered in 5 daily fractions
UCSD Moores Cancer Center
La Jolla, California, United States
Watson Cancer Center
Lakeland, Florida, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Number of Patients With Any Toxicity Related to the Radiation Treatment
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Time frame: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
Number of Participants With Ipsilateral Breast Local Recurrence
Time frame: annually for 2 years post treatment
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