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.