This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Change in the Rate of Adverse Cosmesis (Defined as Fair or Poor Cosmesis) Compared to Baseline Using the Harvard Cosmetic Rating:
Participants end up being rated as fair or poor cosmesis from baseline. Excellent: treated breast nearly identical to untreated breast Good: treated breast slightly different than untreated (minimal but identifiable effects of the treated breast) Fair: Treated breast clearly different from untreated but not seriously distorted (significant radiation effects readily observable) Poor: Treated breast seriously distorted (severe sequelae of breast tissue secondary to radiation effects)
Time frame: Baseline, 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.