Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
American Cancer Society, Inc.
McGill University
University of Kansas Medical Center
Wake Forest University
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.,performing \<150 minutes / week of exercise structured moderate-intensity or strenuous-intensity)
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
You may not be if
Presence of metastatic disease
Any concurrent malignancy requiring active treatment with the exception of selective estrogen receptor modulators and aromatase inhibitors
Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on insulin therapy
Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise or diet on study outcomes
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.
