An observational study in Cardiotoxicity, Heart Failure and Breast Cancer, sponsored by Stony Brook University. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Stony Brook University · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 35 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
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females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab).
Exclusion Criteria:
Association of Heart Failure Biomarkers with Global Longitudinal strain rate
N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
NT-proBNP
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
ST2
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
hs-troponin
Time frame: up to 35 weeks
Prediction of initiation/change in cardiovascular medications based on serum biomarkers
galectin-3
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
galectin-3
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
NT-proBNP
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
hs-troponin
Time frame: up to 35 weeks
Prediction of cardiotoxicity based on serum biomarkers
ST2
Time frame: up to 35 weeks
Association between modifications in chemotherapy with detection of subclinical cardiotoxicity
frequency of chemotherapy changes with subclinical cardiotoxicity
Time frame: up to 10 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Stony Brook University