Assessing the Effects of Exercise on Breast Cancer Biomarkers in Women with Stage 0-III Breast Cancer, ACE Trial

Inclusion Criteria

• Born Female
• History of Stage 0-IIIc breast cancer, diagnosed within the last 5 years
• Completed primary treatment at least 6 months ago
• Able to attend 2 clinic visits at the Fred Hutch Prevention Center for approximately up to 3 hours at a time
• Aged 36-75 years. Younger women will be excluded because a sizable proportion may remain premenopausal and will resume menstruation within 2 years of chemotherapy completion
• Postmenopausal (no menstrual periods in the previous 12 months)
• All race and ethnic groups are eligible for the study
• Able to perform all study requirements, including attendance at clinic visits and capable of responding to questionnaires and clinic and exercise facility instructions in English
• Willing to be randomized
• Willing to consent to release of medical records for their breast cancer diagnosis and treatment
• Capable of providing informed consent
• If a patient has received a cardiotoxic therapy (e.g., Adriamycin, Herceptin), clearance of their oncologist to participated in this study will be required

Exclusion Criteria

• Family history of breast cancer
• If known, BRCA 1/2 mutation carrier
• If known, Li-Fraumeni Syndrome
• Personal history of cancer other than breast: exceptions are non-melanoma skin cancer and cervical neoplasia (CIN)
• Serious health conditions including diabetes, renal disease (e.g., chronic kidney disease), liver disease (e.g., cirrhosis, chronic liver failure), chronic lung disease (chonic obstructive pulmonary disease [COPD], moderate or severe persistent asthma), auto-immune disease requiring oral or inhaled medication, congestive heart failure, or other condition likely to interfere with ability to exercise at moderate levels and undergo bio sampling, or likely to interfere with study outcomes
• Fasting glucose fingerstick > 126 mg/dL
• Taking any medications to treat high blood sugar such as metformin
• Contraindications for exercise testing including: recent (within 6 months) cardiac event (myocardial infarction [MI], pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality, deep vein thrombosis, uncontrolled hypertension (systolic > 200, diastolic > 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, history of cardiac arrest or stroke, or as assessed by an advanced practice practitioner (APP) during the physical exam
• History of clotting disorders
• Unable or unwilling to stop aspirin or nonsteroidal antiinflammatory drugs (NSAIDs) for 48 hours before and after the procedure
• Allergy to anesthetics or local anesthetics
• Long term use of warfarin or similar medications
• Use of medications that could affect exercise ability, blood biomarkers, or muscle biomarkers, including weight loss medications, statins, oral beta-blockers, performance-enhancing drugs, metformin or other diabetic drug, and oral corticosteroids
• Use of any sex hormones (estrogen, progesterone, testosterone or other androgens, for the previous 3 months) of any type including oral, creams, vaginal creams or inserts, patches, implants). Participants will be allowed to be on maintenance anti-estrogen therapy – e.g., tamoxifen, aromatase inhibitors
• Consumption of (on average) more than 2 alcoholic drinks per day
• Current use of any tobacco products including smoking, vaping, chew, nicotine patches
• Frequent marijuana use (>1 per month)
• Current participation in another randomized controlled trial