Could a sweat session rewrite breast cancer risk?
NCT ID NCT02494869
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This study tests whether different amounts of progressive aerobic exercise can reduce risk factors for breast cancer in women who are at high risk. Participants will follow an exercise program, and researchers will measure changes in exercise capacity, body composition, and gene activity in breast tissue. The goal is to see if exercise can positively influence biological markers linked to cancer development.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nonlinear aerobic training (a progressive exercise program)
- What this could lead to
- If exercise dose affects breast cancer risk factors, this could lead to tailored exercise prescriptions for prevention in high-risk women.
- What could go wrong
- The study is early and small, and results may not apply to all women. Exercise may not change risk factors as hoped.
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
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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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75 people
The number who actually took part.
- Started
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Jul 2015
- Expected to finish
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Jul 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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18 years and older
- 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: * Women at high-risk of breast cancer as defined by one of the following: * Cytologically confirmed atypical hyperplasia * Cytologically confirmed LCIS * Being a carrier for * BRCA1 and/or BRCA2 * Predicted lifetime risk of breast cancer \>20% based on family history) * Predicted 10-year risk of breast cancer of ≥ 2.31% * Predicted 5-year risk of breast cancer ≥ 1.67% * Aged 21 ≤ 80 years old * If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. * Women \<50 years old who are of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment. * Must a negative mammogram or negative breast MRI within 1 year of protocol required baseline core biopsy * Clinical breast exam interpreted as benign (not suspicious for cancer) at MSK * Performing less than or equal to 120 minutes of structured moderate-intensity or strenuous-intensity exercise per week * 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 investigator. * Able to achieve an acceptable peek baseline CPET defined as by any of the following criteria: * achieving a plateau in oxygen consumption concurrent an with 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 = 220-Age\[years\]) Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: * Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of randomization, including, but not limited to: (tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole) * Enrollment on an interventional investigational study * Bilateral breast implants * Any newly identified breast abnormality requiring surgical excision * History of any of the following: * Invasive cancer diagnosis * DCIS * Any current invasive cancer diagnosis * Metastatic malignancy of any kind * Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for core biopsy or the trial * Mental impairment leading to inability to cooperate. * Room air desaturation at rest ≤85% * Any of the following absolute contraindications to cardiopulmonary exercise testing and/or aerobic training: * 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 (i.e. infection, renal failure, thyrotoxicosis); or
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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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