|Primary Objective |
To compare patient-reported cosmetic outcome at 3 years using the Breast Cancer Treatment Outcomes Scale (BCTOS) for patients assigned to hypofractionated whole breast irradiation (HF-WBI) versus conventionally fractionated whole breast irradiation (CF-WBI). Specifically, we will compare the 2 treatment arms with respect to the percent of women with adverse cosmetic scores at 3 years after completion of breast conserving surgery, as determined by the patient-reported BCTOS. A score of 2.5 or more indicates an adverse cosmetic outcome.
To determine patient-reported cosmetic outcome using the BCTOS at 6 months, 1, 2, 4, and 5 years.
To determine physician-rated cosmetic outcome at 6 months, 1, 2, 3, 4, and 5 years using the Radiation Therapy and Oncology Group (RTOG) scale for physician assessment. Physician outcome will be determined using photographic assessment and scored by a panel of three attending physicians specializing in breast cancer who will be blinded to the patient randomization arm.
To determine the level of agreement between patient-rated cosmetic outcome and physician-rated cosmetic outcome at the various timepoints assessed.
To determine the 5-year and risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with Ductal carcinoma in situ (DCIS) and early invasive breast cancer.
To determine patient-reported functional status and breast pain using the BCTOS at 6 months, 1, 2, 3, 4, and 5 years after treatment.
To determine maximal acute (within 6 weeks of treatment) and late (more than 6 weeks after treatment) skin and soft tissue toxicities using the NCI CTCAE v4.0 scale.
To determine the relationship between the volume of breast tissue receiving excessive dose (defined as greater than 105% of the prescription dose) and the risk of adverse cosmesis.
To determine the relationship between bra cup size and the risk of adverse cosmesis.
To determine whether there is a statistical interaction between breast volume and volume of tissue receiving greater than 105% of the prescription dose in predicting adverse cosmesis.
To determine in an exploratory analysis whether any other demographic, clinical, and pathologic factors correlate with risk of adverse cosmesis and risk of IBTR.
To determine if the C-509T variant allele of TGF-b is associated with an increased risk of grade 2 or higher fibrosis (as determined by the Subjective, Objective, Medical Management, Analytic [SOMA] scale) three years after completion of radiation.
To compare the cost of radiation for patients treated on the two treatment arms.
To contribute additional blood samples to protocol LAB02-086 which is a case-control study investigating DNA repair phenotypes and genotypes in breast cancer.