Understanding and Predicting Breast Cancer Events After Treatment
UPBEAT
4 other identifiers
interventional
403
1 country
66
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jul 2017
Longer than P75 for not_applicable breast-cancer
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedStudy Start
First participant enrolled
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2034
October 30, 2025
October 1, 2025
17 years
May 20, 2016
October 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Baseline
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.
Baseline and 3 months
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.
Baseline, 3 months and 12 months
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.
Baseline, 3 months, 12 months and 24 months
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.
Baseline, 3 months and 24 months
Change in 6 Minute Walk Results
The purpose of this test is to find out how far the participant can walk in 6 minutes.
Baseline, 3 months, 12 months and 24 months
Secondary Outcomes (17)
Cohen's 4-item Perceived Stress Scale (PSS)
Baseline, 3 months, 12 months, and 24 months
Cook-Medley Hostility Scale
Baseline
Changes in FACT-Fatigue Results
Baseline, 3 months, 12 months, and 24 months
6 Minute Walk Results
Baseline, 3 months, 12 months and 24 months
RAND MOS 36-item Short Form Health Survey (SF-36)
Baseline, 3 months, 12 months and 24 months
- +12 more secondary outcomes
Other Outcomes (2)
B-type natriuretic peptide (BNP)
Baseline and 24 months
Troponin - 1
Baseline and 3 months
Study Arms (2)
Breast Cancer Patients
EXPERIMENTALBreast 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.
Non-Cancer Controls
EXPERIMENTALNon-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
- \> 18 years old
- Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole \[Arimidex\], letrozole \[Femara\], exemestane \[Aromasin\]).
- Able to hold breath for 10 seconds
- ECOG performance status 0 -2
- 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
- Participants in other ongoing clinical trials are eligible for this study
You may not qualify if:
- Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)
- If previously measured, known LVEF \<50%
- Symptomatic claustrophobia
- Unable to provide informed consent
- At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
- 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)
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
IU Health North Hospital
Carmel, Indiana, 46032, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Springmill Medical Center
Indianapolis, Indiana, 46290, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, 48124, United States
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, 48336, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Newton Medical Center
Newton, New Jersey, 07860, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, 24501, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Shenandoah Oncology PC
Winchester, Virginia, 22601, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Related Publications (4)
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.
PMID: 38845066DERIVEDGarg 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.
PMID: 38634292DERIVEDBellissimo 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.
PMID: 37969655DERIVEDBellissimo 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.
PMID: 35775211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Hundley, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
June 7, 2016
Study Start
July 21, 2017
Primary Completion (Estimated)
July 31, 2034
Study Completion (Estimated)
July 31, 2034
Last Updated
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request to NCORP@wakehealth.edu
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.