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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Regular exercisers who are at high risk of developing breast cancer | ≥120 minutes of vigorous-intensity aerobic exercise; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvard Health Professionals survey | Behavioral | Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 2 years |
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Inclusion Criteria:
Cohort 1: Breast Cancer Patients
Cohort 2: High-Risk Patients
Women at high-risk of breast cancer, as defined by one of the following:
Aged 21-80 years old
If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
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:
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:
Any current invasive cancer diagnosis
Metastatic malignancy of any kind
If performing a CPET, any of the following contraindications:
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.
Breast Cancer
MSK clinic
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Scott, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-up) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Tissue from the mastectomy or lumpectomy specimen may be obtained, may either acquire a fresh frozen research tumor and adjacent normal tissue sample or formalin fixed paraffin embedded (FFPE) tissue for molecular profiling Blood and research stool sample (if possible)
| Blood draw | Other | Participant will provide a blood sample |
|
| CPET Procedures | Other | CPET with 12-lead ECG |
|
| stool sample | Other | Research stool sample (within ±1 week of surgery), if possible |
|
| Research Tissue sampling | Procedure | 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. |
|
| Memorial Sloan Kettering Monmouth (Consent and Follow-up) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Consent and Follow-up) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent and Follow-up) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent and Follow-up) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center (Consent and Follow-up) | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent and Follow-up) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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