The Role of suPAR Biomarker in Blood Samples of Breast Cancer Patients During and Post Doxorubicin Chemotherapy: Causative vs. Predictor

Completed

Conditions studied: Doxorubicin Adverse Reaction, Cardiomyopathies, Secondary, Breast Cancer

In brief

This study looks to find a causative or predictive aspect of the suPAR biomarker for heart failure in breast cancer patients receiving Doxorubicin drug chemo regimen. suPAR is a circulating protein which can be found in blood and/or urine and is associated with both kidney and heart disease. * Hypothesis 1: Higher suPAR at baseline will predispose to Doxorubicin-induced cardiomyopathy or heart failure, observed by histology (under the microscope and other lab techniques) in mouse models, and tested using heart ultrasound techniques in humans. * Hypothesis 2: suPAR is a marker of Doxorubicin-induced cardiomyopathy or heart failure after exposure to Doxorubicin, observed by histology (under the microscope and other lab techniques) in mouse models, and tested in humans. The study will look at suPAR's association with three other biomarkers called troponin, B-Type Natriuretic Peptide (BNP) and C- Reactive Protein (CRP) that are also associated with heart disease. In this study, the patient will have blood drawn as a routine part of the cancer treatment. That is prior to starting the cancer therapy, then after the first 2 and last 2 doxorubicin cycles (4 cycles altogether); as well as at 3, 6, \& 12 months after doxorubicin treatment. (6 Visits in total) The patient will also have an echocardiogram (echo, heart ultrasound) at each of these time points. The first of the six study echos is considered part of the routine care.

Key facts

Study ID

NCT03505164

Run by

Rush University Medical Center

People needed

42

Starts

2017-01-17

Expected to finish

2020-07-06

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18 - 64 years
• Undergoing chemotherapy in the Rush cancer center with a plan for doxorubicin (Adriamycin®) chemotherapy.

You may not qualify if…

• Patients with metastatic breast cancer - complicated chemotherapy regimens, higher mortality risk
• HER2 (human epidermal growth factor receptor 2) positive breast cancer patients planned for trastuzumab therapy
• Patients with baseline cardiomyopathy (reduced LVEF: less than 50%)
• Patients with prior cardiovascular history of myocardial infarction (MI), angina, Congestive Heart Disease (CHD) death, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) including percutaneous transluminal coronary angioplasty (PTCA) and end-stage renal disease (ESRD), atrial fibrillation prior to cancer diagnosis
• Atrial fibrillation noted on baseline ECG

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Rush Oak Park Hospital — Oak Park, Illinois, United States

Full record on ClinicalTrials.gov

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