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.
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.
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
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There are 63 Locations for this study
Birmingham Alabama, 35233, United States
Washington District of Columbia, 20010, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Carmel Indiana, 46032, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46290, United States
Kansas City Kansas, 66160, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Dearborn Michigan, 48124, United States
Farmington Hills Michigan, 48336, United States
Grand Rapids Michigan, 49503, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48085, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55454, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Woodbury Minnesota, 55125, United States
Morristown New Jersey, 07960, United States
Newton New Jersey, 07860, United States
Summit New Jersey, 07902, United States
Asheboro North Carolina, 27203, United States
Burlington North Carolina, 27215, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Winston-Salem North Carolina, 27157, United States
Harrisburg Pennsylvania, 17109, United States
Philadelphia Pennsylvania, 19104, United States
York Pennsylvania, 17408, United States
Boiling Springs South Carolina, 29316, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Dallas Texas, 75390, United States
Lynchburg Virginia, 24501, United States
Richmond Virginia, 23230, United States
Richmond Virginia, 23235, United States
Richmond Virginia, 23298, United States
Winchester Virginia, 22601, United States
Seattle Washington, 98195, United States
Burlington Wisconsin, 53105, United States
Fond Du Lac Wisconsin, 54937, United States
Germantown Wisconsin, 53022, United States
Grafton Wisconsin, 53024, United States
Green Bay Wisconsin, 54311, United States
Kenosha Wisconsin, 53142, United States
Milwaukee Wisconsin, 53209, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53233, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53406, United States
Sheboygan Wisconsin, 53081, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
Wauwatosa Wisconsin, 53226, United States
West Allis Wisconsin, 53227, United States
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