Exercise tailored to boost heart health in breast cancer survivors
NCT ID NCT04458532
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This study looks at how different amounts of aerobic exercise (like walking or cycling) over different time periods affect heart and lung fitness in post-menopausal women who had early-stage breast cancer. About 152 women will take part. The goal is to find the best exercise plan to improve how well the body uses oxygen and how healthy the heart and blood vessels are.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Aged 21-80 years * Female * Surgically resected early stage (I-III) primary breast cancer * Post-menopausal, defined as one of the following: * Age ≥ 45 with no menses for at least 2 years * Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist * Estradiol level of ≤30 pg/mL * An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as: * Surgery plus radiation * Surgery plus chemotherapy * Surgery plus trastuzumab * Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)\]. Note: Normative values are available up to 80 years of age) * Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale * Willingness to comply with all study-related procedures. Exclusion Criteria: * Any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 3-5 days of any planned study procedures * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures * Thrombosis of lower extremities * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis) * Presence of any other concurrent, actively treated malignancy * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) * Presence of distant metastatic disease (i.e., stage IV) * Room air desaturation at rest ≤ 85% * Mental impairment leading to inability to cooperate. * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
RECRUITINGHartford, Connecticut, 06102, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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