Breast Cancer Clinical Trial

Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

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.

View Eligibility Criteria

Eligibility Criteria

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 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 is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT03424915

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memoral Sloan Kettering Basking Ridge (Consent and Follow-up)
Basking Ridge New Jersey, 07920, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Memoral Sloan Kettering Monmouth (Consent and Follow-up)
Middletown New Jersey, 07748, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Memorial Sloan Kettering Bergen (Consent and Follow-up)
Montvale New Jersey, 07645, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Memorial Sloan Kettering Commack (Consent and Follow-up)
Commack New York, 11725, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Memoral Sloan Kettering Westchester (Consent and Follow-up)
Harrison New York, 10604, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Memorial Sloan Kettering Cancer Center (Consent and Follow-up)
New York New York, 10065, United States More Info
Lee Jones, PhD
Contact
646-888-8103
Neil Iyengar, MD
Contact
646-888-4714
Lee Jones, PhD
Principal Investigator
Memorial Sloan Kettering Nassau (Consent and Follow-up)
Uniondale New York, 11553, United States More Info
Lee Jones, PhD
Contact
646-888-8103

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT03424915

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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