Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03424915

Run by

Memorial Sloan Kettering Cancer Center

People needed

42

Starts

2018-01-31

Expected to finish

2027-01-01

Last updated by the study team

2026-02-04

Who can join

Age: 21 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

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
• 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.

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
• 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.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent and Follow-up) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Consent and Follow-up) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent and Follow-up) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent and Follow-up) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent and Follow-up) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (Consent and Follow-up) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and Follow-up) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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