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Breast CancerUPBEATNCT02791581

Understanding and Predicting Breast Cancer Events After Treatment

A study testing Cardiac MRI in people with Breast Cancer, run by Wake Forest University Health Sciences at 66 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Cardiac MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
66 sitesUnited States
Study dates
21 Jul 2017to 31 Jul 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy female without known coronary artery disease > 18 years old
  • Able to hold breath 10 seconds
  • ECOG performance status = 0 or 1
  • Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
  • Able to exercise on a treadmill or stationary cycle
  • No personal history of cancer other than superficial skin cancers
  • Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
  • If previously measured, LVEF ≥ 50%

Who cannot join

  • Inflammatory conditions such as lupus or inflammatory bowel disease
  • Overt coronary artery disease or heart failure
  • Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
  • Symptomatic claustrophobia
  • Unable to provide informed consent
  • At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
Show all 22Show fewer
  • Severe pulmonary hypertension
  • Within the past 6 months:
  • Acute pulmonary embolus
  • Deep vein thrombosis
  • Within the past month:
  • Heart attack
  • Unstable or stable angina (cardiac chest pain)
  • Left main coronary artery disease
  • Symptomatic heart failure
  • Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
  • Severe valvular heart disease
  • Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
  • 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

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Beaumont Hospital - Farmington Hills

    Farmington Hills, Michigan, 48336

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Springmill Medical Center

    Indianapolis, Indiana, 46290

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia, 24501

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Newton Medical Center

    Newton, New Jersey, 07860

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Overlook Hospital

    Summit, New Jersey, 07902

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Shenandoah Oncology PC

    Winchester, Virginia, 22601

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • UPMC Memorial

    York, Pennsylvania, 17408

Other trials in United States

About this study

Official title: Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)

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.

Read the detailed description

840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, 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 will be collected.

Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.

Conditions
Breast Cancer
Being tested
Cardiac MRI
Keywords
Breast Cancer, Fatigue, Cardiovascular Events
Medical subject headings
Breast Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac MRIDiagnostic test

    Breast Cancer Patients Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.

    Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months.

Study groups in NCT02791581
Study groupRoleWhat they receive
Breast Cancer PatientsExperimentalBreast 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.
Receives: Diagnostic Test: Cardiac MRI
Non-Cancer ControlsExperimentalNon-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.
Receives: Diagnostic Test: Cardiac MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FACT-Fatigue

    Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

    Measured: Baseline

  2. Change in FACT-Fatigue Results

    Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

    Measured: Baseline and 3 months

  3. Change in FACT-Fatigue Results

    Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

    Measured: Baseline, 3 months and 12 months

  4. Change in FACT-Fatigue Results

    Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

    Measured: Baseline, 3 months, 12 months and 24 months

  5. Change in MRI Exam Results

    The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.

    Measured: Baseline, 3 months and 24 months

  6. Change in 6 Minute Walk Results

    The purpose of this test is to find out how far the participant can walk in 6 minutes.

    Measured: Baseline, 3 months, 12 months and 24 months

Secondary outcomes (17)

  1. Cohen's 4-item Perceived Stress Scale (PSS)

    A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often)

    • weeks four aspects of stress were experienced (1=never to 5=very often)

    Measured: Baseline, 3 months, 12 months, and 24 months

  2. Cook-Medley Hostility Scale

    A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.

    Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.

    Measured: Baseline

  3. Changes in FACT-Fatigue Results

    Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.

    Measured: Baseline, 3 months, 12 months, and 24 months

  4. 6 Minute Walk Results

    The purpose of this test is to find out how far the participant can walk in 6 minutes.

    Measured: Baseline, 3 months, 12 months and 24 months

  5. RAND MOS 36-item Short Form Health Survey (SF-36)

    SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.

    Measured: Baseline, 3 months, 12 months and 24 months

  6. Center for Epidemiological Studies Depression Scale (CESD-10)

    Screening questionnaire assessing depressive symptoms during the last week

    Measured: Baseline, 3 months, 12 months and 24 months

  7. Godin Leisure-Time Exercise Questionnaire (LTEQ)

    Main process measure of physical activity participation

    Measured: Baseline, 3 months, 12 months and 24 months

  8. PACE Adult Sedentary Behaviors Survey

    Assess sedentary lifestyle behaviors

    Measured: Baseline, 3 months, 12 months and 24 months

  9. PROMIS Short Form 8A Measure of Sleep Disturbance

    Assess time course and risk factors associated with sleep disturbance and fatigue

    Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.

    Measured: Baseline, 3 months, 12 months and 24 months

  10. PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A

    Measurement of different aspects of cognitive functioning.

    PROMIS Applied Cognitive Abilities Short Form 8A

    • Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.

    Applied Cognition General Concerns Short Form 8A

    • Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.

    Measured: Baseline, 3 months, 12 months and 24 months

  11. Walking Efficacy for Duration Scale

    Comprised of six items and will be included as a measure of exercise capacity

    Measured: Baseline, 3 months, 12 months and 24 months

  12. Chair Stands - Measures Leg Strength

    Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.

    Measured: Baseline, 3 months, 12 months and 24 months

  13. Standing Balance Test

    Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.

    Measured: Baseline, 3 months, 12 months and 24 months

  14. Gait Speed Test

    Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.

    Measured: Baseline, 3 months, 12 months and 24 months

  15. Grip Strength

    Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.

    Measured: Baseline, 3 months, 12 months and 24 months

  16. Range of Motion

    Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.

    Measured: Baseline, 3 months, 12 months and 24 months

  17. KCCQ-12 Questionnaire

    Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.

    Measured: Baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study start21 Jul 2017
  3. Primary completion31 Jul 2032 (estimated)
  4. Study completion31 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791581
Sponsor's protocol ID
IRB00045463
Other IDs
WF 97415, 1R01CA199167-01, NCI-2017-00386, NCI-2017-00386
Acronym
UPBEAT
Status last verified
Sep 2026
First submitted
20 May 2016
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Publications

  • Avis NE, O'Connell NS, Mihalko SL, Jordan JH, Ladd AC, Lesser GJ, Olson KC, Weaver KE, Dressler EV, Grizzard PJ, Levine B, Moore TL, Ky B, Hackney MH, Brubaker P, Reding KW, Lucas AR, Bellissimo MP, Moeller FG, Kitzman DW, Hamilton CA, Klepin HD, Yeboah J, Ntim W, Zaha VG, D'Agostino R Jr, Hundley WG. Long-Term Fatigue After Treatment for Breast Cancer. JAMA Netw Open. 2026 Aug 3;9(8):e2629862. doi: 10.1001/jamanetworkopen.2026.29862.

    PubMed 42611514

  • Mabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1.

    PubMed 38845066

  • Garg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18.

    PubMed 38634292

  • Bellissimo MP, Canada JM, Jordan JH, Ladd AC, Reding KW, Moore TL, Ntim WO, Heiston EM, Brubaker P, Mihalko SL, D'Agostino R Jr, O'Connell N, Ky B, Wagner LI, Hackney MH, Weaver KE, Lesser GJ, Avis NE, Sutton AL, Lucas AR, Franco RL, Fuemmeler BF, Salloum FN, Hundley WG; UPBEAT Study Group. Physical Activity During Breast Cancer Therapy Associates With Preserved Exercise Capacity and Cardiac Function (WF97415). JACC CardioOncol. 2023 Mar 21;5(5):641-652. doi: 10.1016/j.jaccao.2022.12.011. eCollection 2023 Oct.

    PubMed 37969655

  • Bellissimo MP, Canada JM, Jordan JH, Ladd AC, Heiston EM, Brubaker P, Mihalko SL, Reding K, D Agostino R, O Connell N, Hackney MH, Weaver KE, Lesser GJ, Avis NE, Hundley WG. Changes in Physical Activity, Functional Capacity, and Cardiac Function during Breast Cancer Therapy. Cancer Epidemiol Biomarkers Prev. 2022 Jul 1;31(7):1509. doi: 10.1158/1055-9965.EPI-22-0470.

    PubMed 35775211

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac MRI in people with Breast Cancer, run by Wake Forest University Health Sciences at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACT-Fatigue (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02791581, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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