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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03155802
Other study ID # 922042
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2017
Est. completion date December 2020

Study information

Verified date October 2019
Source Stony Brook University
Contact Michelle Bloom, MD
Phone 6314442031
Email michelle.bloom@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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 (above 3x ULN), or ST2 (above 2x ULN), galectin-3 (above 2x ULN), or hs troponin (above 2x ULN) during baseline screening

5. Patients with metastatic disease or recurrent breast cancer at diagnosis

6. History of other chemotherapy treated malignancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stony Brook Medicine Stony Brook New York

Sponsors (2)

Lead Sponsor Collaborator
Stony Brook University Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Association between modifications in chemotherapy with detection of subclinical cardiotoxicity frequency of chemotherapy changes with subclinical cardiotoxicity up to 10 weeks
Primary Association of Heart Failure Biomarkers with Global Longitudinal strain rate N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate up to 35 weeks
Secondary Prediction of initiation/change in cardiovascular medications based on serum biomarkers NT-proBNP up to 35 weeks
Secondary Prediction of initiation/change in cardiovascular medications based on serum biomarkers ST2 up to 35 weeks
Secondary Prediction of initiation/change in cardiovascular medications based on serum biomarkers hs-troponin up to 35 weeks
Secondary Prediction of initiation/change in cardiovascular medications based on serum biomarkers galectin-3 up to 35 weeks
Secondary Prediction of cardiotoxicity based on serum biomarkers galectin-3 up to 35 weeks
Secondary Prediction of cardiotoxicity based on serum biomarkers NT-proBNP up to 35 weeks
Secondary Prediction of cardiotoxicity based on serum biomarkers hs-troponin up to 35 weeks
Secondary Prediction of cardiotoxicity based on serum biomarkers ST2 up to 35 weeks
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