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Novel Biomarkers and Echocardiography for Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines

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ClinicalTrials.gov Identifier: NCT03155802
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Stony Brook University

Brief 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.

Condition or disease
Cardiotoxicity Heart Failure Breast Cancer Anthracycline Induced Cardiomyopathy Biomarkers Echocardiography

Detailed 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 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.


Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Novel Biomarkers and Echocardiography to Assess Subclinical Cardiac Toxicity in Breast Cancer Patients Receiving Anthracyclines
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Association of Heart Failure Biomarkers with Global Longitudinal strain rate [ Time Frame: up to 35 weeks ]
    N Terminal-proBNP, hs troponin, ST2, galectin-3 with global longitudinal strain rate


Secondary Outcome Measures :
  1. Prediction of initiation/change in cardiovascular medications based on serum biomarkers [ Time Frame: up to 35 weeks ]
    NT-proBNP

  2. Prediction of initiation/change in cardiovascular medications based on serum biomarkers [ Time Frame: up to 35 weeks ]
    ST2

  3. Prediction of initiation/change in cardiovascular medications based on serum biomarkers [ Time Frame: up to 35 weeks ]
    hs-troponin

  4. Prediction of initiation/change in cardiovascular medications based on serum biomarkers [ Time Frame: up to 35 weeks ]
    galectin-3

  5. Prediction of cardiotoxicity based on serum biomarkers [ Time Frame: up to 35 weeks ]
    galectin-3

  6. Prediction of cardiotoxicity based on serum biomarkers [ Time Frame: up to 35 weeks ]
    NT-proBNP

  7. Prediction of cardiotoxicity based on serum biomarkers [ Time Frame: up to 35 weeks ]
    hs-troponin

  8. Prediction of cardiotoxicity based on serum biomarkers [ Time Frame: up to 35 weeks ]
    ST2


Other Outcome Measures:
  1. Association between modifications in chemotherapy with detection of subclinical cardiotoxicity [ Time Frame: up to 10 weeks ]
    frequency of chemotherapy changes with subclinical cardiotoxicity


Biospecimen Retention:   Samples Without DNA
Serum will be kept in -70 oC for future research


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
females between the ages of 18-85 with diagnosis of invasive breast cancer, planned for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155802


Contacts
Contact: Michelle Bloom, MD 6314442031 michelle.bloom@stonybrookmedicine.edu
Contact: Lampros Papadimitriou, MD, PhD 6318467885 lampros.papadimitriou@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11738
Contact: Michelle Bloom, MD    631-444-2031    michelle.bloom@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Gilead Sciences

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT03155802     History of Changes
Other Study ID Numbers: 922042
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Breast Neoplasms
Heart Failure
Cardiomyopathies
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries