Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Inclusion Criteria:

- Aged 21-80 years

- Female

- MSK histologically confirmed early-stage operable breast cancer

- Scheduled to receive chemotherapy in the neoadjvuant or adjuvant setting

- ECOG status of 0 or 1

- Performing less than 150 minutes of structured moderate-intensity or strenuous
intensity exercise per week

- If a female of child-bearing potential, must not be pregnant or planning to become
pregnant during the study.

a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG)
within 2 weeks of beginning chemotherapy.

- Able to complete an acceptable baseline cardiopulmonary exercise test (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 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 ≥ 1.10;

- Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of
age-predicted HRmax [HRmax = 220-Age[years]);

- Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18
on the BORG scale.

- Willingness to be randomized to one of the study arms

Exclusion Criteria:

- Presence of any other concurrent, actively treated malignancy

- History of any other malignancy treated within the past 3 years (other than
non-melanoma skin cancer)

- Presence of metastatic disease

- Any of the following contraindications to cardiopulmonary exercise testing:

- 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

- Room air desaturation at rest ≤ 85%

- Mental impairment leading to inability to cooperate.

- Any other condition or intercurrent illness that, in the opinion of the investigator,
makes the participant a poor candidate for the trial