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Can chemotherapy harm your heart? new study investigates

NCT ID NCT02791581

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how chemotherapy for breast cancer affects the heart, exercise ability, and fatigue. Researchers will compare breast cancer patients to people without cancer using heart MRIs and walking tests. The goal is to better understand and predict heart-related side effects after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand and predict heart problems in breast cancer patients after chemotherapy.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct changes in care, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

403 people

The number who actually took part.

Started

Jul 2017

Expected to finish

Jul 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Fatigue

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024, United States

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142, United States

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209, United States

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226, United States

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406, United States

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105, United States

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022, United States

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937, United States

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124, United States

  • Beaumont Hospital - Farmington Hills

    Farmington Hills, Michigan, 48336, United States

  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia, 24501, United States

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403, United States

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Health Partners Inc

    Minneapolis, Minnesota, 55454, United States

  • IU Health North Hospital

    Carmel, Indiana, 46032, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Newton Medical Center

    Newton, New Jersey, 07860, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204, United States

  • Overlook Hospital

    Summit, New Jersey, 07902, United States

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640, United States

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615, United States

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650, United States

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672, United States

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316, United States

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Randolph Hospital

    Asheboro, North Carolina, 27203, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109, United States

  • Shenandoah Oncology PC

    Winchester, Virginia, 22601, United States

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503, United States

  • Springmill Medical Center

    Indianapolis, Indiana, 46290, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Memorial

    York, Pennsylvania, 17408, United States

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • United Hospital

    Saint Paul, Minnesota, 55102, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, 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

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235, United States

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904, United States

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081, United States

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23230, United States

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085, United States

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.