Echocardiogram for Breast Cancer
(POCEB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a tailored approach to heart imaging can reduce unnecessary tests while still detecting early heart problems in women undergoing HER2-targeted therapy for breast cancer. Participants will either receive regular echocardiograms (heart ultrasounds) or have the frequency adjusted based on their risk of heart issues. Women with HER2-positive breast cancer, scheduled for about a year of HER2-targeted therapy, can consider joining, especially if they have not experienced serious heart problems before. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart health monitoring for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this echocardiogram protocol is safe for breast cancer patients?
Research has shown that echocardiograms safely assess heart health in breast cancer patients. They use no radiation and have no known side effects. One study found that echocardiograms did not increase the risk of death or heart failure in patients with early breast cancer. Another study reported that a small number (4.8%) of patients experienced heart issues after using echocardiograms for monitoring. However, these issues might relate to the cancer treatment itself, not the echocardiogram. Overall, echocardiograms provide a safe and well-tolerated method for monitoring heart function during breast cancer treatment.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the use of echocardiograms to tailor heart monitoring for breast cancer patients receiving trastuzumab. Unlike the standard approach, which involves regular echocardiograms every three months, this trial investigates a more personalized imaging schedule based on the patient's risk of heart failure. This could lead to fewer unnecessary procedures for low-risk patients and more targeted monitoring for those at intermediate risk, potentially improving patient care and resource efficiency.
What evidence suggests that this echocardiogram strategy is effective for detecting cardiotoxicity in breast cancer patients?
Research has shown that echocardiograms are useful for checking heart health in patients receiving HER2-targeted therapy for breast cancer. In this trial, participants will be divided into two groups to assess the frequency of echocardiogram monitoring. The Standard-of-care Group will receive echocardiograms before cycles 1, 5, 9, and 13 of trastuzumab and another after completion. The Judicious-imaging Group will have echocardiograms based on their risk of heart failure, with low-risk participants receiving them every 6 months and intermediate-risk participants every 4 months. One study found that only 4.8% of patients had serious heart problems when monitored with echocardiograms, indicating that regular heart checks can catch issues early. Another study found that 87% of patients on HER2 therapies had heart screenings, highlighting their importance in treatment plans. Echocardiograms help ensure patients can safely continue their cancer treatments while monitoring their heart health.26789
Are You a Good Fit for This Trial?
This trial is for women diagnosed with early-stage breast cancer who are receiving HER2-targeted therapy. Participants should be able to undergo heart imaging and follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HER2-targeted therapy with echocardiogram imaging at specified intervals based on risk stratification
Follow-up
Participants are monitored for safety and effectiveness after completion of trastuzumab
What Are the Treatments Tested in This Trial?
Interventions
- Echocardiogram
Trial Overview
The study is testing whether using a personalized schedule for heart ultrasounds (echocardiograms) can safely reduce unnecessary scans while still catching any heart problems early in women getting HER2-targeted treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab).
Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Citations
Rationale and design of a cardiac safety study for reduced ...
This study seeks to evaluate whether less frequent cardiotoxicity surveillance (every 6 months) is safe for patients receiving a non-anthracycline HER2- ...
Effectiveness of surveillance by echocardiography for ...
The main findings of this study were 1) the composite outcome of CTRCD and acute heart failure was present in 4.8 % of the patients with breast ...
3.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/cardiac-surveillance-for-anti-her2-chemotherapy-the-case-for-a-more-focused-approachCardiac Surveillance for Anti-HER2 Chemotherapy - Consult QD
This article discusses what drove the current FDA cardiac surveillance strategy for anti-HER2 therapy and the challenges it poses in practice and clinical ...
Imaging Versus Cardiac Biomarker Monitored HER2 ...
Antibodies (trastuzumab and pertuzumab) directed against HER2 have in addition to traditional chemotherapy significantly improved survival in HER2 positive ...
Left ventricular ejection fraction (EF) screening in ...
Results: 147 HER2 positive metastatic breast cancer patients receiving HER2 blocking therapy were identified. 87% underwent ≥ 1 echo or MUGA cardiac screening ...
Does cardiac imaging surveillance strategy influence ... - PMC
The selection of pretreatment echocardiography or MUGA did not influence the risk of death or heart failure in patients with early breast cancer.
7.
dailynews.ascopubs.org
dailynews.ascopubs.org/do/monitoring-breast-cancer-survivors-long-term-echocardiogram-surveillance-identifiesMonitoring Breast Cancer Survivors With Long-Term ...
Monitoring Breast Cancer Survivors With Long-Term Echocardiogram Surveillance Identifies Those at Risk for Cardiac Dysfunction. July 22, 2024.
Contemporary Role of Echocardiography for Clinical ...
Recent primary prevention studies in women with breast cancer have demonstrated safety and attenuation in LVEF decline with candesartan (21) and bisoprolol ...
Detailed Echocardiographic Phenotyping in Breast Cancer ...
A number of studies have demonstrated early and late abnormalities in left ventricular ejection fraction (LVEF). However, data on the changes in ...
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