Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

NCT03424915 | Active Not Recruiting

• 1 other identifier: 18-058
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 7

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; 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;

Behavioral: Harvard Health Professionals survey; Procedure: Research Tissue sampling

Interventions

Blood draw OTHER

Participant will provide a blood sample

Regular exercisers and non-exercising groups who have been diagnosed with breast cancer

CPET Procedures OTHER

CPET with 12-lead ECG

Regular exercisers and non-exercising groups who have been diagnosed with breast cancer

stool sample OTHER

Research stool sample (within ±1 week of surgery), if possible

Regular exercisers and non-exercising groups who have been diagnosed with breast cancer

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.

Regular exercisers and non-exercising groups who have been diagnosed with breast cancer; Regular exercisers who are at high risk of developing breast cancer

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.

Regular exercisers and non-exercising groups who have been diagnosed with breast cancer; Regular exercisers who are at high risk of developing breast cancer

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSK clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

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

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow-up)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent and Follow-up)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent and Follow-up)

Harrison, New York, 10604, United States

Location

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

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow-up)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jessica Scott, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: January 31, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (7)