The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation
Study Type
OBSERVATIONAL
Enrollment
100
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Global Longitudinal Strain (GLS)
Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS.
Time frame: Baseline, 6 Months
Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography
Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction \<50%.
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Radiation-induced Lung Parenchymal Changes Using CT Imaging
Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks.
Time frame: Baseline, 3,6,12, months post treatment
Incidence of Thyroid Dysfunction
Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks.
Time frame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
Incidence of Ipsilateral Arm Lymphedema
Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.
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Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Severity of Ipsilateral Arm Lymphedema
Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Ipsilateral Breast/Chest Wall Cosmesis
Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks.
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment