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Can exercise alter breast tumors? new study investigates

NCT ID NCT03424915

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 regular exercise might change the biology of breast tumors in women with early-stage breast cancer. Researchers will compare tumor and normal tissue samples from 42 women who exercise regularly versus those who don't. The goal is to understand if exercise affects tumor genetics and immune response, which could guide future research on lifestyle and cancer.

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 design future trials that test whether exercise changes breast tumor biology, potentially leading to new lifestyle-based approaches for cancer management.
What could go wrong
This is a small, observational study (42 participants) that only looks at past exercise habits, not a controlled intervention. It cannot prove cause and effect, and results may not apply to all breast cancer 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.

Participants

42 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Jan 2027

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.

Who is studied

MSK clinic

Ages

21 to 80 years

Sex

Female participants only

Healthy volunteers

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

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

Inclusion Criteria: Cohort 1: Breast Cancer Patients * Ages 21-80 years * Female * Histologically confirmed ER receptor positive (\>1% staining), HER2 negative (FISH ratio \<1.8), untreated operable breast cancer * Stage I to II disease * Scheduled for surgical resection by any type of mastectomy or lumpectomy at MSK * Tumor size ≥1cm by preoperative imaging or physical examination * Categorization into self-reported exercise history exposure classifications as follows: (1) exercising: ≥120 minutes of vigorous-intensity exercise/wk for the past 12 months, and (2) sedentary (non-exercising): ≤ 30 minutes of moderate-intensity exercise/week for the past months using the Harvard Health Professionals survey.(34) * Ability to read and understand English * Willing and able to comply with requirements of the protocol Cohort 2: High-Risk Patients * Women at high-risk of breast cancer, as defined by one of the following: * Cytologically confirmed atypical hyperplasia * 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 of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment. Exclusion Criteria: Cohort 1: * Received any form of neoadjuvant treatment * Presence of any other concurrent, actively treated malignancy * Presence of metastatic disease * If performing a CPET, any of the following contraindications: * 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). * Mental impairment leading to inability to cooperate * If performing a CPET, room air desaturation at rest ≤ 85% * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the study. Cohort 2: * Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of consent, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole. * Enrollment on an interventional investigational study * Bilateral breast implants * History of any of the following: * Invasive breast cancer * DCIS * Any current invasive cancer diagnosis * Metastatic malignancy of any kind * If performing a CPET, any of the following contraindications: * 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). * Mental impairment leading to inability to cooperate * If performing a CPET, room air desaturation at rest ≤ 85% * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the core biopsy or the study.

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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.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent and Follow-up)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (Consent and Follow-up)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent and Follow-up)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent and Follow-up)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent and Follow-up)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent and Follow-up)

    Harrison, New York, 10604, United States

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