Cardiac MRI for Breast Cancer
(UPBEAT Trial)

Recruiting in Palo Alto (17 mi)

+65 other locations

Overseen byGregory Hundley, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

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.

+5 more

Exclusion Criteria

Pregnant women and women who are breast-feeding

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

Your heart's pumping ability is less than 50%.

+5 more

Participant Groups

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.

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.