This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.
The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race. Patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. After 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.
Study Type
OBSERVATIONAL
Enrollment
200
The study will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Change in Left Ventricular Ejection Fraction (LVEF)
Absolute change in LVEF by echocardiogram at follow-up
Time frame: through study completion (expected to be 15 years)
Cancer therapy-related cardiac dysfunction (CTRCD)
Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value \< 50%
Time frame: through study completion (expected to be 15 years)
Symptomatic Heart Failure (HF)
Incidence of symptomatic heart failure (centrally adjudicated)
Time frame: through study completion (expected to be 15 years)
Change in Longitudinal Strain
Change in longitudinal strain by echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in Circumferential Strain
Change in circumferential strain by echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in Diastolic function
Change in diastolic function defined as E/e' by echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in Left Ventricular (LV) Mass
Change in LV Mass by echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in Relative LV Wall Thickness
Change in relative LV wall thickness from baseline
Time frame: through study completion (expected to be 15 years)
Change in Ventricular-Arterial Coupling
Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in LV Twist
Change in LV Twist measured by 3D echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in LV Torsion
Change in LV Torsion measured by 3D echo from baseline
Time frame: through study completion (expected to be 15 years)
Change in NTproBNP
Change in NTproBNP measured in batches from banked samples from baseline.
Time frame: through study completion (expected to be 15 years)
Change in high-sensitivity troponin (hsTnT)
Change in hs-TnT measured in batches from banked samples from baseline.
Time frame: through study completion (expected to be 15 years)
Change in patient reported fatigue
Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue.
Time frame: through study completion (expected to be 15 years)
Change in patient reported quality of life
Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient.
Time frame: through study completion (expected to be 15 years)
Change in patient reported activity level
Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.
Time frame: through study completion (expected to be 15 years)
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