Understanding and Predicting Breast Cancer Events after Treatment in Patients with Stage I-III Breast Cancer
This randomized clinical trial studies understanding and predicting breast cancer events after treatment in patients with stage I-III breast cancer. Understanding and predicting events after cancer treatment may help to establish guidelines for reducing exercise intolerance, fatigue, cardiovascular events, and improving overall survival for patients treated for stage I-III breast cancer.
Inclusion Criteria
- Stage I-III female breast cancer (including inflammatory and newly diagnosed, or locally recurrent 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
- Eastern Cooperative Oncology Group (ECOG) 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
- CONTROL (HEALTHY) GROUP: Healthy female without known coronary artery disease
- CONTROL (HEALTY) GROUP: > 18 years old
- CONTROL (HEALTHY) GROUP: Able to hold breath for 10 seconds
- CONTROL (HEALTHY) GROUP: ECOG performance status 0-1
- CONTROL (HEALTHY) GROUP: Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
- CONTROL (HEALTHY) GROUP: Able to exercise on a treadmill or stationary cycle
- CONTROL (HEALTHY) GROUP: No personal history of cancer other than superficial skin cancers
- CONTROL (HEALTHY) GROUP: Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
Exclusion Criteria
- Those with ferromagnetic cerebral aneurysm clips or other intraorbital/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, left ventricular ejection fraction (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 (systolic blood pressure [SBP] > 180 mm Hg or diastolic blood pressure [DBP] > 120 mm Hg) * Severe valvular heart disease * Uncontrolled metabolic disease (diabetes with fasting blood sugar [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
- CONTROL (HEALTHY) GROUP: Inflammatory conditions, such as rheumatoid arthritis, systemic lupus or inflammatory bowel disease
- CONTROL (HEALTHY) GROUP: Overt coronary artery disease or heart failure
- CONTROL (HEALTHY) GROUP: Those with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
- CONTROL (HEALTHY) GROUP: If previously measured, known LVEF < 50%
- CONTROL (HEALTHY) GROUP: Symptomatic claustrophobia
- CONTROL (HEALTHY) GROUP: Unable to provide informed consent
- CONTROL (HEALTHY) GROUP: At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled
- CONTROL (HEALTHY) GROUP: Severe pulmonary hypertension
- CONTROL (HEALTHY) GROUP: Within the past 6 months: * Acute pulmonary embolus * Deep vein thrombosis
- CONTROL (HEALTHY) GROUP: 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
- CONTROL (HEALTHY) GROUP: Patient does not understand English
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02791581.
PRIMARY OBJECTIVES:
I. To determine the incidence and time course of alterations in left ventricle (LV) and aortic function, exercise capacity and fatigue in women treated for stage I-III breast cancer.
II. To determine which baseline demographic, behavioral, and psychosocial cardiovascular (CV) risk factors are associated with the development of LV/aortic dysfunction, impaired exercise capacity, symptomatic fatigue, disability, and CV events.
III. To determine if adjuvant chemotherapy (Adj-C) (with/without radiation therapy [XRT]) associated changes in serum biomarkers or other CV risk factors precede the onset of LV/aortic dysfunction, exercise intolerance, symptomatic fatigue, disability, or CV events.
IV. To determine if existing American Heart Association (AHA) or other risk factor models forecast the future development of CV events in women that received Adj-C for breast cancer relative to historical forecasts in women not receiving Adj-C.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo magnetic resonance imaging (MRI) over 10-15 minutes to measure CV function, neurocognitive tests, 6-minute walk test, and disability measures comprising of chair stands, standing balance, gait speed test, grip strength, and range of motion and complete questionnaires at baseline and 3, 12, and 24 months.
ARM II: Patients undergo MRI over 10-15 minutes to measure CV function, neurocognitive tests, 6-minute walk test, disability measures comprising of chair stands, standing balance, gait speed test, grip strength, and range of motion and complete questionnaires at baseline and 3, 12, and 24 months. Patients also undergo a treadmill or stationary bike cardiopulmonary exercise test (CPET) to measure maximal (peak VO2) exercise capacity at baseline and 24 months.
After completion of study, patients are followed up annually for up to 11 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationWake Forest NCORP Research Base
Principal InvestigatorWilliam Gregory Hundley
- Primary ID97415
- Secondary IDsNCI-2017-00386, WF-97415
- ClinicalTrials.gov IDNCT02791581