Moffitt logo

Clinical Trials Search

Clinical Trial 20734

Cancer Type: Breast
Study Type: Prevention
NCT#: NCT02791581

Phase: N/A
Prinicipal Investigator: Roohi Ismail-Khan

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Understanding and Predicting Breast Cancer Events after Treatment (UPBEAT)

Summary

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.

Objective

Objective 1: To determine the incidence and time course of alterations in LV and aortic function, exercise capacity and fatigue in women treated for Stage I-III breast cancer. How are these changes interrelated, and how do they impact 7-year occurrence of CV events (myocardial infarction, cardiac death, and symptomatic HF) upon receipt of anthracycline or non-anthracycline-based chemotherapy? Objective 2: To determine which baseline demographic, behavioral, and psychosocial CV risk factors are associated with the development of LV/aortic dysfunction, impaired exercise capacity, symptomatic fatigue, disability, and CV events. Objective 3: To determine if Adj-C (with/without 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.

Treatments

Therapies

Medications

Inclusion Criteria

  • 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
  • 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

  • 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 > Symptomatic claustrophobia
  • 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
  • Severe valvular heart disease
  • Uncontrolled metabolic disease
  • Aortic aneurism (>45 mm diameter) or aortic dissection
  • Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
  • Hypertrophic obstructive cardiomyopathy
  • 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
  • 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
  • Severe valvular heart disease
  • Uncontrolled metabolic disease
  • Aortic aneurism (>45 mm diameter) or aortic dissection
  • Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
  • Hypertrophic obstructive cardiomyopathy

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.