Aerobic Exercise Training in Lowering the Risk of Breast Cancer in Patients at High-Risk for Development of Breast Cancer
- Women at high-risk of breast cancer, as defined by one of the following: * Cytologically confirmed atypical hyperplasia * Cytologically confirmed lobular breast carcinoma in situ (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%
- If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study * Women < 50 years old who are of child-bearing potential must have a negative pregnancy test (urine human chorionic gonadotropin [HCG] or serum) within 14 days of enrollment
- Must have a negative mammogram or negative breast magnetic resonance imaging (MRI) within 1 year of protocol-required baseline core biopsy
- Clinical breast exam interpreted as benign (not suspicious for cancer) at Memorial Sloan Kettering (MSK)
- Performing less than or equal to 120 minutes of structured moderate-intensity or strenuous-intensity exercise per week
- Able to complete an acceptable baseline cardiopulmonary exercise testing (CPET) in the absence of high risk electrocardiography (ECG) findings or other inappropriate response to exercise as determined by the investigator
- Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output * A respiratory exchange ratio of >= 1.10 * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 beats per minute [bpm] of age-predicted HRmax) * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >= 18 on the BORG scale
- 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 breast cancer * Ductal breast carcinoma in situ (DCIS)
- 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)
I. To determine the dose-response of aerobic training on the gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for the development of breast cancer.
I. To determine the dose-response of aerobic training on proinflammatory profile in epithelial cells and surrounding stroma.
II. To determine the dose-response of aerobic training on changes in circulating angiome/proinflammatory growth factors.
III. To determine the dose-response of aerobic training on exercise capacity.
IV. To determine the dose-response of aerobic training on body composition.
V. Frozen and paraffin embedded tissue will be archived for future exploratory studies.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM A: Patients undergo instructor-led aerobic exercise training sessions for 25 minutes 3 times per week for up to 24 weeks. (Arm closed March 18, 2018)
ARM B: Patients undergo instructor-led aerobic exercise training sessions for 50 minutes 3 times per week for up to 24 weeks.
ARM C: Patients undergo instructor-led aerobic exercise training sessions for 60 minutes 5 times per week for up to 24 weeks. A minimum of 3 sessions per week are required to be instructor-led while the remaining 2 sessions can be instructor-led or home-based.
ARM D: Patients undergo in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of normal daily activity.
After completion of study, patients are followed up for 24 months.
Trial Phase Phase NA
Trial Type Prevention
Memorial Sloan Kettering Cancer Center
Neil M. Iyengar
- Primary ID 15-093
- Secondary IDs NCI-2016-01776
- Clinicaltrials.gov ID NCT02494869