Understanding and Predicting Breast Cancer Events After Treatment

Breast Cancer Clinical Trial

— UPBEAT  

Official title:

Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02791581
• Other study ID #: IRB00045463
• Secondary ID: WF 974151R01CA19
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: July 31, 2034

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 403
• Est. completion date: July 31, 2034
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Cardiac MRI
Breast Cancer Patients Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Randolph Hospital	Asheboro	North Carolina
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina
United States	Tufts Medical Center	Boston	Massachusetts
United States	Aurora Cancer Care-Southern Lakes VLCC	Burlington	Wisconsin
United States	Cone Health Cancer Center at Alamance Regional	Burlington	North Carolina
United States	IU Health North Hospital	Carmel	Indiana
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Beaumont Hospital - Dearborn	Dearborn	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Prisma Health Cancer Institute - Easley	Easley	South Carolina
United States	Beaumont Hospital - Farmington Hills	Farmington Hills	Michigan
United States	Aurora Health Center-Fond du Lac	Fond Du Lac	Wisconsin
United States	Aurora Health Care Germantown Health Center	Germantown	Wisconsin
United States	Aurora Cancer Care-Grafton	Grafton	Wisconsin
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	UPMC Pinnacle Cancer Center/Community Osteopathic Campus	Harrisburg	Pennsylvania
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Springmill Medical Center	Indianapolis	Indiana
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Aurora Cancer Care-Kenosha South	Kenosha	Wisconsin
United States	Centra Lynchburg Hematology-Oncology Clinic Inc	Lynchburg	Virginia
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Aurora Cancer Care-Milwaukee	Milwaukee	Wisconsin
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Health Partners Inc	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Newton Medical Center	Newton	New Jersey
United States	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Aurora Cancer Care-Racine	Racine	Wisconsin
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	University of Washington Medical Center - Montlake	Seattle	Washington
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	Vince Lombardi Cancer Clinic-Sheboygan	Sheboygan	Wisconsin
United States	Aurora Medical Center in Summit	Summit	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	Moffitt Cancer Center	Tampa	Florida
United States	Moffitt Cancer Center - McKinley Campus	Tampa	Florida
United States	William Beaumont Hospital - Troy	Troy	Michigan
United States	Vince Lombardi Cancer Clinic-Two Rivers	Two Rivers	Wisconsin
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Aurora Cancer Care-Milwaukee West	Wauwatosa	Wisconsin
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas
United States	Shenandoah Oncology PC	Winchester	Virginia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	UPMC Memorial	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B-type natriuretic peptide (BNP)	Serum BNP as a predictor of exercise intolerance	Baseline and 24 months
Other	Troponin - 1	Acquired to determine associations between troponin levels during therapy and the onset of cardiac and vascular dysfunction, exercise capacity, and fatigue.	Baseline and 3 months
Primary	FACT-Fatigue	Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.	Baseline
Primary	Change in FACT-Fatigue Results	Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.	Baseline and 3 months
Primary	Change in FACT-Fatigue Results	Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.	Baseline, 3 months and 12 months
Primary	Change in FACT-Fatigue Results	Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.	Baseline, 3 months, 12 months and 24 months
Primary	Change in MRI Exam Results	The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.	Baseline, 3 months and 24 months
Primary	Change in 6 Minute Walk Results	The purpose of this test is to find out how far the participant can walk in 6 minutes.	Baseline, 3 months, 12 months and 24 months
Secondary	Cohen's 4-item Perceived Stress Scale (PSS)	A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often); o weeks four aspects of stress were experienced (1=never to 5=very often)	Baseline, 3 months, 12 months, and 24 months
Secondary	Cook-Medley Hostility Scale	A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.; Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.	Baseline
Secondary	Changes in FACT-Fatigue Results	Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.	Baseline, 3 months, 12 months, and 24 months
Secondary	6 Minute Walk Results	The purpose of this test is to find out how far the participant can walk in 6 minutes.	Baseline, 3 months, 12 months and 24 months
Secondary	RAND MOS 36-item Short Form Health Survey (SF-36)	SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.	Baseline, 3 months, 12 months and 24 months
Secondary	Center for Epidemiological Studies Depression Scale (CESD-10)	Screening questionnaire assessing depressive symptoms during the last week	Baseline, 3 months, 12 months and 24 months
Secondary	Godin Leisure-Time Exercise Questionnaire (LTEQ)	Main process measure of physical activity participation	Baseline, 3 months, 12 months and 24 months
Secondary	PACE Adult Sedentary Behaviors Survey	Assess sedentary lifestyle behaviors	Baseline, 3 months, 12 months and 24 months
Secondary	PROMIS Short Form 8A Measure of Sleep Disturbance	Assess time course and risk factors associated with sleep disturbance and fatigue; Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.	Baseline, 3 months, 12 months and 24 months
Secondary	PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A	Measurement of different aspects of cognitive functioning.; PROMIS Applied Cognitive Abilities Short Form 8A; - Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.; Applied Cognition General Concerns Short Form 8A; - Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.	Baseline, 3 months, 12 months and 24 months
Secondary	Walking Efficacy for Duration Scale	Comprised of six items and will be included as a measure of exercise capacity	Baseline, 3 months, 12 months and 24 months
Secondary	Chair Stands - Measures Leg Strength	Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.	Baseline, 3 months, 12 months and 24 months
Secondary	Standing Balance Test	Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.	Baseline, 3 months, 12 months and 24 months
Secondary	Gait Speed Test	Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.	Baseline, 3 months, 12 months and 24 months
Secondary	Grip Strength	Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.	Baseline, 3 months, 12 months and 24 months
Secondary	Range of Motion	Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.	Baseline, 3 months, 12 months and 24 months
Secondary	KCCQ-12 Questionnaire	Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.	Baseline, 24 months