High Risk for Developing Breast CancerNCT02494869
Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer
A study testing Nonlinear Aerobic Training, Height, Weight, BMI measure and Blood draw in people with High Risk for Developing Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk for Developing Breast Cancer
- What is being tested?
- Nonlinear Aerobic Training, Height, Weight, BMI measure and Blood draw
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
- Conditions
- High Risk for Developing Breast Cancer
- Being tested
- Nonlinear Aerobic Training, Height, Weight, BMI measure, Blood draw, Cardiopulmonary exercise test
- Keywords
- Aerobic Training, Exercise, Gene Expression, 15-093
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonlinear Aerobic TrainingBehavioural
Height, Weight, BMI measureOther
Blood drawOther
Cardiopulmonary exercise testOther
| Study group | Role | What they receive |
|---|---|---|
| Nonlinear Aerobic Training (75 minutes/week) closed to accrual | Experimental | The ultimate goal is for participants to complete 75 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the (CPETs performed at baseline, midpoint, and Study Follow-Up. The 75 min/wk will be achieved via 3 individual supervised aerobic training sessions at approximately 25 minutes/session.All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study. This arm is closed to accrual. Receives: Behavioral: Nonlinear Aerobic Training; Other: Height, Weight, BMI measure; Other: Blood draw; Other: Cardiopulmonary exercise test |
| Nonlinear Aerobic Training (150 minutes/week) | Experimental | The ultimate goal is for participants to complete 150 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the CTPETs test performed at baseline, midpoint, and Study Follow-Up. The 150 minutes/week will be achieved by completing 3 aerobic training sessions/week for approximately 50 minutes/session. All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study. Receives: Behavioral: Nonlinear Aerobic Training; Other: Height, Weight, BMI measure; Other: Blood draw; Other: Cardiopulmonary exercise test |
| Nonlinear Aerobic Training (300 minutes/week) | Experimental | The ultimate goal is for participants to complete 300 minutes/week of aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from CPETs performed at baseline, midpoint, and Study Follow-Up. The 300 minutes/week will be achieved by completing 5 aerobic training sessions/week for approximately 60 minutes/session. A minimum of 3 sessions/week are required to be supervised while the remaining 2 sessions can be supervised or unsupervised home-based. Participants on all Arms will receive a heart rate monitor prior to beginning unsupervised home-based aerobic training sessions. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines. Receives: Behavioral: Nonlinear Aerobic Training; Other: Height, Weight, BMI measure; Other: Blood draw; Other: Cardiopulmonary exercise test |
| General Physical Activity | Active comparator | Usual care patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to records type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress and answer questions. Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer
Fresh-frozen tissue sections from normal breast epithelial cell samples before and after aerobic training will be cut and stained using hematoxylin \& eosin, and the morphological features will be reviewed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk for Developing Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494869
- Sponsor's protocol ID
- 15-093
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2015
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Scott JM, Lee J, Michalski MG, Batch K, Simpson AL, Peoples J, Lee CP, Harrison JN, Yu AF, Sasso JP, Dang C, Moskowitz CS, Jones LW, Eves ND. Mechanisms of Exercise Intolerance Across the Breast Cancer Continuum: A Pooled Analysis of Individual Patient Data. Med Sci Sports Exerc. 2024 Apr 1;56(4):590-599. doi: 10.1249/MSS.0000000000003348. Epub 2023 Nov 27.
PubMed 38485730
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer
- ClinicalTrials.gov ID
- NCT02494869
- Acronym / sponsor ID
- 15-093
- Conditions
- High Risk for Developing Breast Cancer
- Keywords
- Aerobic Training, Exercise, Gene Expression, 15-093
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nonlinear Aerobic Training (75 minutes/week) closed to accrual | Experimental | Behavioral: Nonlinear Aerobic Training, Other: Height, Weight, BMI measure, Other: Blood draw, Other: Cardiopulmonary exercise testThe ultimate goal is for participants to complete 75 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the (CPETs performed at baseline, midpoint, and Study Follow-Up. The 75 min/wk will be achieved via 3 individual supervised aerobic training sessions at approximately 25 minutes/session.All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study. This arm is closed to accrual. |
| Nonlinear Aerobic Training (150 minutes/week) | Experimental | Behavioral: Nonlinear Aerobic Training, Other: Height, Weight, BMI measure, Other: Blood draw, Other: Cardiopulmonary exercise testThe ultimate goal is for participants to complete 150 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the CTPETs test performed at baseline, midpoint, and Study Follow-Up. The 150 minutes/week will be achieved by completing 3 aerobic training sessions/week for approximately 50 minutes/session. All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study. |
| Nonlinear Aerobic Training (300 minutes/week) | Experimental | Behavioral: Nonlinear Aerobic Training, Other: Height, Weight, BMI measure, Other: Blood draw, Other: Cardiopulmonary exercise testThe ultimate goal is for participants to complete 300 minutes/week of aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from CPETs performed at baseline, midpoint, and Study Follow-Up. The 300 minutes/week will be achieved by completing 5 aerobic training sessions/week for approximately 60 minutes/session. A minimum of 3 sessions/week are required to be supervised while the remaining 2 sessions can be supervised or unsupervised home-based. Participants on all Arms will receive a heart rate monitor prior to beginning unsupervised home-based aerobic training sessions. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines. |
| General Physical Activity | Active comparator | Other: Blood drawUsual care patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to records type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress and answer questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Women at high-risk of breast cancer as defined by one of the following:
- Being a carrier for
- 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
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonlinear Aerobic Training | Behavioural | Nonlinear Aerobic Training (150 minutes/week), Nonlinear Aerobic Training (300 minutes/week), Nonlinear Aerobic Training (75 minutes/week) closed to accrual |
| Height, Weight, BMI measure | Other | Nonlinear Aerobic Training (150 minutes/week), Nonlinear Aerobic Training (300 minutes/week), Nonlinear Aerobic Training (75 minutes/week) closed to accrual |
| Blood draw | Other | General Physical Activity, Nonlinear Aerobic Training (150 minutes/week), Nonlinear Aerobic Training (300 minutes/week), Nonlinear Aerobic Training (75 minutes/week) closed to accrual |
| Cardiopulmonary exercise test | Other | Nonlinear Aerobic Training (150 minutes/week), Nonlinear Aerobic Training (300 minutes/week), Nonlinear Aerobic Training (75 minutes/week) closed to accrual |
Primary outcome
gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer
Time frame: 2 years
Fresh-frozen tissue sections from normal breast epithelial cell samples before and after aerobic training will be cut and stained using hematoxylin \& eosin, and the morphological features will be reviewed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Derived from this study: PubMed 38485730Scott JM, Lee J, Michalski MG, Batch K, Simpson AL, Peoples J, Lee CP, Harrison JN, Yu AF, Sasso JP, Dang C, Moskowitz CS, Jones LW, Eves ND. Mechanisms of Exercise Intolerance Across the Breast Cancer Continuum: A Pooled Analysis of Individual Patient Data. Med Sci Sports Exerc. 2024 Apr 1;56(4):590-599. doi: 10.1249/MSS.0000000000003348. Epub 2023 Nov 27.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Scott, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonlinear Aerobic Training, Height, Weight, BMI measure and Blood draw in people with High Risk for Developing Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.