Breast Cancer Clinical Trial
Official title:
Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
This is a pilot prospective cohort study, in adult female subjects 18-85 years old with a diagnosis of invasive breast cancer who are planned for anthracycline-inclusive chemotherapy and followed up for a time period of 6 months post completion of anthracycline chemotherapy. They will participate in blood and imaging tests with a goal of determining the best method for predicting the occurrence of cardiotoxicity in this subpopulation.
Anthracyclines and other chemotherapy agents are associated with cardiotoxicity. The risk of
cardiac related toxicity is increased in patients with advanced age, with multiple comorbid
conditions, and those needing prolonged or intensive treatment. These patients require a
tailored approach to surveillance, early diagnosis and treatment of cardiac issues related to
cancer therapy, with timely decision making with respect to alterations in therapy. A serum
biomarker approach alone or in combination with imaging indices holds promise for early
identification, risk stratification and monitoring of chemotherapy related cardiotoxicity.
Thirty-five consecutive adult females between the ages of 18-85 with diagnosis of invasive
breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/-
trastuzumab) will be enrolled.
A detailed medical history (interim where appropriate), physical exam, collection of blood
samples for the measurement of Heart Failure (HF) biomarkers (and standard chemistry and
hematology parameters), electrocardiogram and a 2D/3D echo cardiogram including the
measurement of global longitudinal strain will be performed at baseline, mid chemotherapy, at
the end of chemotherapy and 6 months post the completion of chemotherapy. (echocardiogram
will not be done during chemotherapy).
The hypothesis being tested in this prospective trial is whether early changes in the levels
of serum biomarkers of stress (N terminal pro B-type natriuretic peptide (NT-proBNP)),
inflammation (ST2), necrosis (hs troponin), and fibrosis (galectin-3) will correlate with
changes in sub-clinical left ventricular dysfunction as assessed by 3-dimensional (3D)
echocardiogram with speckle tracking/strain in breast cancer patients receiving anthracycline
based chemotherapy.
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