NCT07474090
Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial
Recruiting
NAAges 18–85InterventionalSupportive careWake Forest University Health SciencesInvestigator-initiated
~120 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Exercise InterventionEducational InterventionSupportive CareBiospecimen CollectionMagnetic Resonance ImagingQuestionnaire Administration
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak oxygen consumption (VO2)
Measured over At baseline and 24 weeks
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesNorth Carolina2
Study leadership
- Glenn Lesser, MD · STUDY_CHAIR · Wake Forest University Health Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received ≥ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable
Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy
Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group
Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report
Able to hold breath for 8 seconds
Must be able to read and understand English language
Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program
Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program
Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed
Exclusion
At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):
Symptomatic claustrophobia
Pregnancy or breast-feeding
Ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders
Uncontrolled hypertension (systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 100 mm Hg)
Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician
Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/min)
Atrial fibrillation with uncontrolled ventricular response (\> 130 beats per minute \[bpm\])
Unstable or stable angina (cardiac chest pain)
Severe pulmonary hypertension
Left main coronary artery disease
Symptomatic heart failure
Severe valvular heart disease
Aortic aneurysm (\> 45 mm diameter) or aortic dissection
Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
Hypertrophic obstructive cardiomyopathy
Acute myocardial infarction within 28 days of enrollment
Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment
Plans to relocate within 6 months of enrollment and unable to participate in study procedures
May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial
May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior)
May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination
What this trial measures
- Peak oxygen consumption (VO2)At baseline and 24 weeks
Will be assessed using cardiopulmonary exercise testing. VO2max, the maximum rate of oxygen consumption measured during incremental exercise, is the gold standard measure of aerobic fitness. It is expressed in milliliters of oxygen consumed per minute per kilogram of body weight (ml/kg/min). Higher VO2max measurements show better function, as it allows one to produce more energy, thereby performing more work.
- Left ventricular ejection fraction (LVEF)At baseline and 24 weeks
Will be assessed using cardiac magnetic resonance imaging (CMR). Left ventricular ejection fraction (LVEF) typically refers to the left side of the heart. It shows how much oxygen-rich blood is pumped out of the left ventricle to most of the body's organs with each contraction. It a percentage, ranging from 0-100%. LVEF helps determine the severity of dysfunction on the left side of the heart. Higher values of LVEF represent better heart function.