Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT02791581

Understanding and Predicting Breast Cancer Events After Treatment

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

403

Start Date

2017-07-21

Completion Date

2034-07-31

Last Updated

2025-10-30

Healthy Volunteers

Yes

Conditions

Breast Cancer

Interventions

DIAGNOSTIC_TEST

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.

Inclusion Criteria for Women with Stage I - III Breast Cancer: * 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 Exclusion Criteria for Women with Stage I-III Breast Cancer: * 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) * 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 Inclusion Criteria for Women Free of Cancer for Comparison: * 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 for Women Free of Cancer for Comparison: * 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

Locations (66)

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

Clinical Research Directory

Understanding and Predicting Breast Cancer Events After Treatment

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (66)