Breast Cancer Clinical Trial

Understanding and Predicting Breast Cancer Events After Treatment

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

403

Study ID:

NCT02791581

Recruitment Status:

Active, not recruiting

Sponsor:

Wake Forest University Health Sciences

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There are 63 Locations for this study

See Locations Near You

University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Moffitt Cancer Center - McKinley Campus
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Northwestern University
Chicago Illinois, 60611, United States
IU Health North Hospital
Carmel Indiana, 46032, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Springmill Medical Center
Indianapolis Indiana, 46290, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Beaumont Hospital - Farmington Hills
Farmington Hills Michigan, 48336, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy Michigan, 48085, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Health Partners Inc
Minneapolis Minnesota, 55454, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Newton Medical Center
Newton New Jersey, 07860, United States
Overlook Hospital
Summit New Jersey, 07902, United States
Randolph Hospital
Asheboro North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington North Carolina, 27215, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg Pennsylvania, 17109, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
UPMC Memorial
York Pennsylvania, 17408, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg Virginia, 24501, United States
Virginia Cancer Institute
Richmond Virginia, 23230, United States
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Shenandoah Oncology PC
Winchester Virginia, 22601, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington Wisconsin, 53105, United States
Aurora Health Center-Fond du Lac
Fond Du Lac Wisconsin, 54937, United States
Aurora Health Care Germantown Health Center
Germantown Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha Wisconsin, 53142, United States
Aurora Cancer Care-Milwaukee
Milwaukee Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53233, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine Wisconsin, 53406, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers Wisconsin, 54241, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

403

Study ID:

NCT02791581

Recruitment Status:

Active, not recruiting

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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