This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.

840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.

Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.

Inclusion Criteria for Women with Stage I - III Breast Cancer:

• Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
• > 18 years old
• Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin]).
• Able to hold breath for 10 seconds
• ECOG performance status 0 -2
• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
• Able to exercise on a treadmill or stationary cycle
• Participants in other ongoing clinical trials are eligible for this study

Exclusion Criteria for Women with Stage I-III Breast Cancer:

• Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)

• If previously measured, known LVEF <50%

• Symptomatic claustrophobia

• Unable to provide informed consent

• At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.

• Severe pulmonary hypertension

• Within the past 6 months:

  • Acute pulmonary embolus
  • Deep vein thrombosis

• Within the past month:

  • Heart attack
  • Unstable or stable angina (cardiac chest pain)
  • Left main coronary artery disease
  • Symptomatic heart failure
  • Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
  • Severe valvular heart disease
  • Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
  • Aortic aneurism (>45 mm diameter) or aortic dissection
  • Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
  • Hypertrophic obstructive cardiomyopathy

• Patient does not understand English

Inclusion Criteria for Women Free of Cancer for Comparison:

• Healthy female without known coronary artery disease > 18 years old
• Able to hold breath 10 seconds
• ECOG performance status = 0 or 1
• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
• Able to exercise on a treadmill or stationary cycle
• No personal history of cancer other than superficial skin cancers
• Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
• If previously measured, LVEF ≥ 50%

Exclusion Criteria for Women Free of Cancer for Comparison:

• Inflammatory conditions such as lupus or inflammatory bowel disease

• Overt coronary artery disease or heart failure

• Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices

• Symptomatic claustrophobia

• Unable to provide informed consent

• At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.

• Severe pulmonary hypertension

• Within the past 6 months:

  • Acute pulmonary embolus
  • Deep vein thrombosis

• Within the past month:

  • Heart attack
  • Unstable or stable angina (cardiac chest pain)
  • Left main coronary artery disease
  • Symptomatic heart failure
  • Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
  • Severe valvular heart disease
  • Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
  • Aortic aneurism (>45 mm diameter) or aortic dissection
  • Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
  • Hypertrophic obstructive cardiomyopathy

• Patient does not understand English

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

6 months after publication for a 2 year duration

upon request to NCORP@wakehealth.edu