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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])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 12 months and 24 months
Awards & highlights
UPBEAT Trial 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.Check my eligibility
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.See study design
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.
UPBEAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
UPBEAT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 6 Minute Walk Results
Change in FACT-Fatigue Results
Change in MRI Exam Results
+1 moreSecondary outcome measures
6 Minute Walk Results
Center for Epidemiological Studies Depression Scale (CESD-10)
Chair Stands - Measures Leg Strength
+14 moreOther outcome measures
B-type natriuretic peptide (BNP)
Troponin - 1
UPBEAT 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
~3240
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,003,780 Total Patients Enrolled
32 Trials studying Breast Cancer
4,637 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,750 Total Patients Enrolled
939 Trials studying Breast Cancer
1,542,957 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.In the past month, I haven't had major heart issues or trouble understanding English.Your heart's pumping ability is less than 50%.I have severe high blood pressure in the lungs.I have early to locally advanced breast cancer, not spread far, and am seeking a cure.I am scheduled for chemotherapy or hormone therapy for my cancer.You can hold your breath for 10 seconds.I can take care of myself and perform daily activities.I can walk 2 blocks without feeling chest pain or shortness of breath.You can walk on a treadmill or use a stationary bike.You can't be in another clinical trial at the same time.I have not had a blood clot in my lungs or deep veins in the past 6 months.I experience severe fear in enclosed spaces.I am unable to understand and give consent for treatment.You have certain metal devices in your head or body that are not safe for MRI scans.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Cancer Controls
- Group 2: Breast Cancer Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any sites within North America conducting this medical investigation?
"The current trial is available at 66 distinct sites, including Saint Paul, Green Bay and Lynchburg. It would be wise to elect the closest centre in order to reduce transportation requirements if you join in."
Answered by AI
What are the primary goals of this clinical research?
"The key metric for this clinical trial, to be monitored at Baseline, 3 months, 12 months and 24 months is the FACT-Fatigue index. Supplementary metrics include KCCQ-12 Questionnaire (assessing heart failure symptoms, physical/social limitations in a 2-week window), CESD-10 Screening questionnaire (depressive symptoms over last week) and the Godin Leisure-Time Exercise Questionnaire (LTEQ; measuring physical activity)."
Answered by AI
Are there any vacancies in this research program for participants?
"The information provided on clinicaltrials.gov reflects that the enrolment phase of this trial is complete and no longer actively seeking participants. Initially published in July 2017, its last update was August 2022; however, there are 2603 other trials still recruiting right now."
Answered by AI
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