| Eligibility |
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
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