Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer

This is an interventional prevention trial for High Risk for Developing Breast Cancer focused on measuring Aerobic Training, Exercise, Gene Expression, 15-093 Read More

Inclusion Criteria:

• Women at high-risk of breast cancer as defined by one of the following:

  • Cytologically confirmed atypical hyperplasia
  • Cytologically 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 who are of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment.
• Must a negative mammogram or 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 or equal to 120 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
• 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