Understanding and Predicting Breast Cancer Events After Treatment
NCT ID: NCT02791581
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
403 participants
INTERVENTIONAL
2017-07-21
2034-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Breast Cancer Patients
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.
Cardiac MRI
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.
Non-Cancer Controls
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.
Cardiac MRI
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.
Interventions
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Cardiac MRI
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
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Inclusion Criteria
* \> 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
* 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%
Exclusion Criteria
* 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)
* 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
* 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.
* 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
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Gregory Hundley, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
IU Health North Hospital
Carmel, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Springmill Medical Center
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Newton Medical Center
Newton, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Randolph Hospital
Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Memorial
York, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Shenandoah Oncology PC
Winchester, Virginia, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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WF 97415
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2017-00386
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2017-00386
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB00045463
Identifier Type: -
Identifier Source: org_study_id
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