Breast CancerNCT03424915
Exercise, Fitness and Tumor Profiling in Breast Cancer Patients
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Harvard Health Professionals survey, Blood draw and CPET Procedures
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Jan 2018to Jan 2027
- Phase
- Observational
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MSK clinic
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent and Follow-up)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Follow-up)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow-up)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (Consent and Follow-up)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Uniondale, New York, 11553
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Harvard Health Professionals survey, Blood draw, CPET Procedures, stool sample, Research Tissue sampling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvard Health Professionals surveyBehavioural
Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.
Blood drawOther
Participant will provide a blood sample
CPET ProceduresOther
CPET with 12-lead ECG
stool sampleOther
Research stool sample (within ±1 week of surgery), if possible
Research Tissue samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Harvard Health Professionals survey; Other: Blood draw; Other: CPET Procedures; Other: stool sample; Procedure: Research Tissue sampling | |
| Regular exercisers who are at high risk of developing breast cancer | ≥120 minutes of vigorous-intensity aerobic exercise; Receives: Behavioral: Harvard Health Professionals survey; Procedure: Research Tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in DNA somatic mutational profile
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.
Measured: 2 years
differences in RNA sequencing
The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq
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 posted7 Feb 2018
- Study start31 Jan 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424915
- Sponsor's protocol ID
- 18-058
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure
- ClinicalTrials.gov ID
- NCT03424915
- Acronym / sponsor ID
- 18-058
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- City of Hope Medical Center
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Feb 2018 (actual)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular exercisers and non-exercising groups who have been diagnosed with breast cancer | – | Behavioral: Harvard Health Professionals survey, Other: Blood draw, Other: CPET Procedures, Other: stool sample, Procedure: Research Tissue samplingThere 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. |
| Regular exercisers who are at high risk of developing breast cancer | – | Behavioral: Harvard Health Professionals survey, Procedure: Research Tissue sampling≥120 minutes of vigorous-intensity aerobic exercise; |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSK clinic
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (51 listed)
- 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:
- Mental impairment leading to inability to cooperate
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 |
|---|---|---|
| Harvard Health Professionals surveyParticipants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months. | Behavioural | Regular exercisers and non-exercising groups who have been diagnosed with breast cancer, Regular exercisers who are at high risk of developing breast cancer |
| Blood drawParticipant will provide a blood sample | Other | Regular exercisers and non-exercising groups who have been diagnosed with breast cancer |
| CPET ProceduresCPET with 12-lead ECG | Other | Regular exercisers and non-exercising groups who have been diagnosed with breast cancer |
| stool sampleResearch stool sample (within ±1 week of surgery), if possible | Other | Regular exercisers and non-exercising groups who have been diagnosed with breast cancer |
| Research Tissue samplingSample 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. | Procedure or surgery | Regular exercisers and non-exercising groups who have been diagnosed with breast cancer, Regular exercisers who are at high risk of developing breast cancer |
Primary outcome
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.
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
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 7 Oct 2026.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 21 inclusion and 51 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
differences in DNA somatic mutational profile (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.