A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
The purpose of this study is to find out what effects, if any, exercise and a plant-based
 diet have on aromatase levels in postmenopausal women who are overweight and being treated
 with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other
 ways diet and exercise may affect your body (for example, changing the way your breast tissue
 expresses or makes genes) and your quality of life.
Inclusion Criteria:

 -  Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast
 cancer

 -  Completed anti-HER2 therapy, if HER2-positive

 -  Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical
 ovarian suppression

 -  At least 3 months post completion of chemotherapy, if administered

 -  At least 3 months post radiation, if administered

 -  Receiving adjuvant endocrine therapy with an aromatase inhibitor (anastrozole,
 letrozole, exemestane)

 -  ECOG performance status of 0 to 1

 -  Sedentary (i.e., <150 minutes / week of exercise)

 -  Age ≥ 18

 -  BMI ≥ 27

 -  Able to achieve an acceptable peak baseline CPET, as defined by any of the following
 criteria and in the absence of high risk ECG findings or other inappropriate response
 to exercise as determined by the investigator:

 -  Achieved 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., within10 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 comply with all study-related procedures

 -  Intact breast available for biopsy

 Exclusion Criteria:

 -  Presence of metastatic disease

 -  Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on
 medical therapy

 -  Enrollment onto any other therapeutic investigational study

 -  Mental impairment leading to inability to cooperate

 -  Any of the following contraindications to exercise:

 1. Acute myocardial infarction within 3-5 days of any planned study procedures;

 2. Unstable angina

 3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise

 4. Recurrent syncope

 5. Active endocarditis

 6. Acute myocarditis or pericarditis

 7. Symptomatic severe aortic stenosis

 8. Uncontrolled heart failure

 9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned
 study procedures

 10. Thrombosis of lower extremities

 11. Suspected dissecting aneurysm

 12. Uncontrolled asthma

 13. Pulmonary edema

 14. Respiratory failure

 15. Acute non-cardiopulmonary disorders that may affect exercise performance

 -  Any other condition or intercurrent illness that, in the opinion of the investigator,
 makes the subject a poor candidate for study participation.

 -  Nut or legume allergy

 -  Concurrent participation in weight loss or other exercise programs