New York, New York 10065


Purpose:

This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.


Criteria:

Inclusion Criteria: - Women at high-risk of breast cancer as defined by one of the following: - Cytologically confirmed atypical hyperplasia - Cytologically confirmed LCIS - BRCA1 and/or BRCA2 mutation carriers - 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% - Postmenopausal women, defined as: - Age > 45 with no menses for at least 2 years - Age < 80 years old - Weight <205 kilograms - Must a negative mammogram or negative breast MRI within 1 year of protocol required baseline core biopsy o Patients positive for BRCA mutations must have a negative breast MRI within 1 year of protocol-required baseline core biopsy - Clinical breast exam interpreted as benign (not suspicious for cancer) at MSK - Performing less than 75 minutes of structured moderate-intensity or strenuous-intensity exercise per week - Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. - Able to achieve an acceptable peek baseline CPET defined as by any of the following criteria: - achieving a plateau in oxygen consumption concurrent an with increase in power output; - a respiratory exchange ratio ≥ 1.10; - attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted [HRmax = 220-Age[years]) Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: - Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of randomization, including, but not limited to: (tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole) - Enrollment on an interventional investigational study - Bilateral breast implants - Any newly identified breast abnormality requiring surgical excision - History of any of the following: - Invasive cancer diagnosis - DCIS - Flat epithelial atypia - Any current invasive cancer diagnosis - Metastatic malignancy of any kind - Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for core biopsy or the trial - Mental impairment leading to inability to cooperate. - Room air desaturation at rest ≤85% - Any of the following absolute contraindications to cardiopulmonary exercise testing and/or aerobic training: - 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); or


NCT ID:

NCT02494869


Primary Contact:

Principal Investigator
Lee Jones, PhD
Memorial Sloan Kettering Cancer Center

Lee Jones, PhD
Phone: 646-888-8103


Backup Contact:

Neil Iyengar, MD
Phone: 646-888-4714


Location Contact:

New York, New York 10065
United States

Lee Jones, PhD
Phone: 646-888-4698

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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