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Cardiac MRI for Breast Cancer (UPBEAT Trial)

N/A

Waitlist Available

Led By Gregory Hundley, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged over 18 years

Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin])

Must not have

Within the past month: Heart attack, Unstable or stable angina, Left main coronary artery disease, Symptomatic heart failure, Uncontrolled hypertension, Severe valvular heart disease, Uncontrolled metabolic disease, Aortic aneurism (>45 mm diameter) or aortic dissection, Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise, Hypertrophic obstructive cardiomyopathy, Patient does not understand English

Severe pulmonary hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 12 months and 24 months

Awards & highlights

Summary

This trial is testing if chemotherapy for breast cancer patients affects the heart, ability to exercise, and fatigue compared to those without cancer.

Who is the study for?

This trial is for women over 18 with Stage I-III breast cancer, who can hold their breath for 10 seconds, walk two blocks without severe symptoms, and exercise on a treadmill or cycle. They should be scheduled to receive certain chemotherapies or estrogen blockers but not have heart issues, uncontrolled hypertension, recent clots or attacks, metal implants incompatible with MRI, or severe pulmonary conditions.

What is being tested?

The study aims to understand if chemotherapy for breast cancer impacts heart health compared to those without cancer. It involves using Cardiac MRI to monitor the heart's condition during treatment and assess any changes in exercise capacity and fatigue levels.

What are the potential side effects?

While this study does not involve drugs that cause side effects directly since it uses Cardiac MRI as an intervention; however, participants may experience discomfort from lying still inside the MRI machine and anxiety due to claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am scheduled for chemotherapy or hormone therapy for my cancer.

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I can take care of myself and perform daily activities.

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I can walk 2 blocks without feeling chest pain or shortness of breath.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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In the past month, I haven't had major heart issues or trouble understanding English.

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I have severe high blood pressure in the lungs.

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I experience severe fear in enclosed spaces.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 12 months and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 12 months and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 12 months and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6 Minute Walk Results

Change in FACT-Fatigue Results

Change in MRI Exam Results

+1 more

Secondary study objectives

6 Minute Walk Results

Center for Epidemiological Studies Depression Scale (CESD-10)

Chair Stands - Measures Leg Strength

+14 more

Other study objectives

B-type natriuretic peptide (BNP)

Troponin - 1

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-Cancer ControlsExperimental Treatment1 Intervention

Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.

Group II: Breast Cancer PatientsExperimental Treatment1 Intervention

Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cardiac MRI

2017

Completed Phase 4

~3210

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,266 Previous Clinical Trials

1,013,304 Total Patients Enrolled

34 Trials studying Breast Cancer

4,684 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,597 Total Patients Enrolled

944 Trials studying Breast Cancer

1,543,561 Patients Enrolled for Breast Cancer

Gregory Hundley, MDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

285 Total Patients Enrolled

2 Trials studying Breast Cancer

285 Patients Enrolled for Breast Cancer

Media Library

Cardiac MRI Clinical Trial Eligibility Overview. Trial Name: NCT02791581 — N/A

Breast Cancer Research Study Groups: Non-Cancer Controls, Breast Cancer Patients

Breast Cancer Clinical Trial 2023: Cardiac MRI Highlights & Side Effects. Trial Name: NCT02791581 — N/A

Cardiac MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT02791581 — N/A

~9 spots leftby Nov 2024

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