Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

February 2, 2026 updated by: Memorial Sloan Kettering Cancer Center

Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure

This study is designed to find out how engaging in regular exercise (or not) alters the biology of breast tumors as well as the normal tissue (if available) surrounding the tumor. The investigators hope that findings from this initial study will guide the design of future studies to examine how changes in exercise alter breast tumor biology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow-up)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and Follow-up)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent and Follow-up)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Consent and Follow-up)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (Consent and Follow-up)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent and Follow-up)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MSK clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer
There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
Behavioral: Harvard Health Professionals survey
Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.
Other: Blood draw
Participant will provide a blood sample
Other: CPET Procedures
CPET with 12-lead ECG
Other: stool sample
Research stool sample (within ±1 week of surgery), if possible
Procedure: Research Tissue sampling
Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.
Regular exercisers who are at high risk of developing breast cancer
≥120 minutes of vigorous-intensity aerobic exercise;
Behavioral: Harvard Health Professionals survey
Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.
Procedure: Research Tissue sampling
Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
differences in DNA somatic mutational profile
Time Frame: 2 years
Eight-μm-thick representative sections of the fresh-frozen sample will be microdissected with a needle under a stereomicroscope (Olympus SZ61), to ensure >70% of tumor cell content as previously described.(36) Matched germline DNA will be microdissected from adjacent normal breast tissue (if available) for each case; to avoid the possibility of morphologically appearing non-neoplastic cells harboring somatic mutations; we will prioritize the microdissection of stromal cells and avoid normal breast ducts and lobules.
2 years
differences in RNA sequencing
Time Frame: 2 years
The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Scott, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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