UnknownNot Applicable

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

United States35 participantsStarted 2017-04-18

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

FEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female subjects aged 18-85 years old
. Biopsy-proven diagnosis of invasive breast cancer carcinoma
. Plan for anthracycline inclusive chemotherapy (+/- taxanes, +/- trastuzumab)

Exclusion criteria

. 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%)
. History of known obstructive coronary artery disease (CAD), or coronary revascularization within the past 1 year
. History of clinical heart failure or previous heart failure hospitalization

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Association of Heart Failure Biomarkers with Global Longitudinal strain rate

Timeframe: up to 35 weeks

Trial details

NCT IDNCT03155802

SponsorStony Brook University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

Contact for this trial

Michelle Bloom, MD

6314442031 michelle.bloom@stonybrookmedicine.edu

View on ClinicalTrials.gov More Cardiotoxicity trials