Understanding and Predicting Breast Cancer Events after Treatment in Patients with Stage I-III Breast Cancer

Status: Active

Description

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.

Eligibility Criteria

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)
  • Scheduled to receive chemotherapy
  • 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 (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 history of cancer
  • CONTROL (HEALTHY) GROUP: Never received chemotherapy, radiation therapy, immunotherapy, or had breast surgery

Exclusion Criteria

  • Those with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices
  • 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] > 100mm 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
  • 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 > 100mm 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

Locations & Contacts

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Springmill Medical Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu

Michigan

Dearborn
Beaumont Hospital – Dearborn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
William Beaumont Hospital-Royal Oak
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Troy
William Beaumont Hospital - Troy
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

North Carolina

Asheboro
Randolph Hospital
Status: Active
Contact: Site Public Contact
Phone: 336-832-0836
Email: vivian.sheidler@conehealth.com
Burlington
Cone Health Cancer Center at Alamance Regional
Status: Active
Contact: Site Public Contact
Phone: 336-538-7725
Email: kaye.shoffner@conehealth.com
Greensboro
Cone Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 336-832-0821
Email: vivian.sheidler@conehealth.com
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-474-9892

South Carolina

Easley
Greenville Health System Cancer Institute-Easley
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org

Virginia

Lynchburg
Centra Lynchburg Hematology-Oncology Clinic Inc
Status: Active
Contact: Site Public Contact
Phone: 434-200-5925
Email: Kevin.Patel@centrahealth.com
Richmond
VCU Massey Cancer Center at Stony Point
Status: Active
Contact: William Gregory Hundley
Email: gundley@wakehealth.edu
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1939
Email: mwellons@vcu.edu

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org

Trial Objectives and Outline

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 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 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 7-9.5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
William Gregory Hundley

Trial IDs

Primary ID 97415
Secondary IDs WF-97415, NCI-2017-00386
Clinicaltrials.gov ID NCT02791581