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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00588 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98118 | Other Identifier | Wake Forest University Health Sciences | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies how well a stress test works in detecting heart damage in premenopausal women with stage I-III breast cancer. Giving a stress test with adenosine or regadenoson and cardiovascular magnetic resonance imaging may help doctors detect heart damage caused by breast cancer treatments including chemotherapy and aromatase inhibitors.
PRIMARY OBJECTIVES:
I. To describe decrements in left ventricular myocardial microcirculatory perfusion reserve in premenopausal women treated with an aromatase inhibitor for high-risk hormone receptor-positive breast cancer and in premenopausal women treated without an aromatase inhibitor for triple negative breast cancer over three to six months of in the first 24 months on an aromatase inhibitor or after cessation of chemotherapy, respectively.
SECONDARY OBJECTIVES:
I. To describe changes between the cohorts with hormone receptor-positive and triple negative breast cancer in other measures of cardiovascular function as measured by myocardial rest T1 (myocardial fibrosis burden) and left ventricular ejection fraction (LVEF) measured noninvasively with cardiovascular magnetic resonance (CMR) imaging over three to six months.
II. To describe the relationship of clinical and demographic variables in relation to their potential contribution to changes in left ventricular myocardial microcirculatory perfusion reserve over three to six months in both groups.
III. To study the overall feasibility of accruing and retaining premenopausal women with stage I-III breast cancer in a trial using adenosine stress CMR to assess myocardial perfusion reserve (MPR) and other parameters of cardiovascular health.
OUTLINE:
Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy, participants undergo a stress test which consists of receiving adenosine intravenously (IV) over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60 minutes at baseline and then 3-6 months later.
After completion of study, participants are followed up at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (stress test) | Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy, participants undergo a stress test which consists of receiving adenosine IV over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60 minutes at baseline, and again 3-6 months later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine | Biological | Given IV |
| |
| Magnetic Resonance Imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion reserve index (MPRI) | Will first estimate 95% confidence intervals for each group at each time point as well as for the change from baseline to 3-6-months in each group. | Baseline and 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial rest myocardial fibrosis burden (T1) and left ventricular ejection fraction (LVEF) | Will be used to correlate myocardial perfusion with T1 and myocardial function (LVEF). | Baseline and 3-6 months |
| Change in MPRI measures |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with stage I-III breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Emily Douglas | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Procedure |
Undergo CMR imaging |
|
|
| Regadenoson | Drug | Given IV |
|
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| Stress Management Therapy | Procedure | Undergo stress test |
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Change in MPRI measures (overall and within each group) will be compared using 2-sample t-tests for binary variables. Correlations will be estimated between BMI and the change in MPRI measures.
| Baseline to 3-6 months |
| Accrual rate defined as based on the number of patients who participate compared to the total number of patients approached | Will capture data for those approached and consenting or declining and any reasons given for declining participation into the study. Will be assessed by estimating counts and percent's and corresponding 95% Clopper-Pearson exact binomial confidence intervals. Will be compared to the total number of patients enrolled. | Baseline and 3-6 months |
| Retention rate defined the number of patients who are enrolled and complete both assessments | Will be assessed by estimating counts and percent's and corresponding 95% Clopper-Pearson exact binomial confidence intervals. Will be compared to the total number of patients enrolled. | Baseline and 3-6 months |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D009682 | Magnetic Resonance Spectroscopy |
| C430916 | regadenoson |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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