Novel Biomarkers and Echocardiography for Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/17/2017 |
| Start Date: | April 18, 2017 |
| End Date: | December 2018 |
| Contact: | Michelle Bloom, MD |
| Email: | michelle.bloom@stonybrookmedicine.edu |
| Phone: | 6314442031 |
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.
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 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 or 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.
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 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 or 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.
Inclusion Criteria:
1. Female subjects aged 18-85 years old
2. Biopsy-proven diagnosis of invasive breast cancer carcinoma
3. Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)
Exclusion Criteria:
1. History of major heart disease at the time of breast cancer diagnosis (myocardial
infarction or known left ventricular dysfunction (LVD) at baseline (defined as
ejection fraction <40%)
2. History of known obstructive coronary artery disease (CAD), or coronary
revascularization within the past 1 year
3. History of clinical heart failure or previous heart failure hospitalization
4. Patients with elevations in NT-pro BNP (within 2x ULN), or ST2, galectin-3, or hs
troponin above ULN during baseline screening
5. Patients with metastatic disease or recurrent breast cancer at diagnosis
6. History of other chemotherapy treated malignancy
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