20 Participants NeededMy employer runs this trial

Echocardiogram for Breast Cancer

(POCEB Trial)

KL
Overseen ByKaily LaForce
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Rochester
Must be taking: HER2-targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Baseline left ventricular ejection fraction (LVEF) ≥ 55% by 2-D echocardiography
I am a woman between 18 and 79 years old.
Ability to provide informed consent
See 1 more

Exclusion Criteria

Pregnancy or lactation
Inability to comply with study procedures
I have atrial fibrillation or serious heart valve disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HER2-targeted therapy with echocardiogram imaging at specified intervals based on risk stratification

12 months
Echocardiograms every 3-6 months depending on risk group

Follow-up

Participants are monitored for safety and effectiveness after completion of trastuzumab

3 months
1 echocardiogram within 100 days after completion

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

Group I: Judicious-imaging GroupExperimental Treatment1 Intervention
Group II: Standard-of-care GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

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 ...

Cardiac 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.

Monitoring 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 ...