Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

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 of 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.