Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)

Status: Active_not_recruiting
Location: See all (66) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• 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%

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
Moffitt Cancer Center
Tampa
Moffitt Cancer Center - McKinley Campus
Tampa
Illinois
Northwestern University
Chicago
Indiana
IU Health North Hospital
Carmel
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Springmill Medical Center
Indianapolis
Kansas
University of Kansas Cancer Center
Kansas City
University of Kansas Hospital-Westwood Cancer Center
Westwood
Massachusetts
Tufts Medical Center
Boston
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Beaumont Hospital - Dearborn
Dearborn
Beaumont Hospital - Farmington Hills
Farmington Hills
Spectrum Health at Butterworth Campus
Grand Rapids
William Beaumont Hospital-Royal Oak
Royal Oak
William Beaumont Hospital - Troy
Troy
Minnesota
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Minnesota Oncology Hematology PA-Woodbury
Woodbury
North Carolina
Randolph Hospital
Asheboro
Cone Health Cancer Center at Alamance Regional
Burlington
Novant Health Presbyterian Medical Center
Charlotte
Duke University Medical Center
Durham
Cone Health Cancer Center
Greensboro
Wake Forest University Health Sciences
Winston-salem
New Jersey
Morristown Medical Center
Morristown
Newton Medical Center
Newton
Overlook Hospital
Summit
Pennsylvania
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
University of Pennsylvania/Abramson Cancer Center
Philadelphia
UPMC Memorial
York
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Prisma Health Cancer Institute - Easley
Easley
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Virginia
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg
VCU Massey Cancer Center at Stony Point
Richmond
Virginia Cancer Institute
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
Shenandoah Oncology PC
Winchester
Washington
University of Washington Medical Center - Montlake
Seattle
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Aurora Health Center-Fond du Lac
Fond Du Lac
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Time Frame
Start Date: 2017-07-21
Completion Date: 2034-07-31
Participants
Target number of participants: 403
Treatments
Experimental: Breast Cancer Patients
Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.~Baseline: Collect 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.~Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.
Experimental: Non-Cancer Controls
Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers.~Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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