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1

Carvedilol and Empagliflozin to Prevent Heart Problems During Treatment for People with Stage I-IV HER2+ Breast Cancer

HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial

Purpose: To study the ability of carvedilol (Coreg®) and/or empagliflozin (Jardiance®) heart disease medications to prevent heart problems caused by anti-HER2 targeted therapy.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) breast cancer who are planning to receive anti-HER2 targeted therapy. You must not be planning to receive doxorubicin (Adriamycin®). You must be receiving care at Washington University. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®), by mouth, daily for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®), by mouth, daily for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care (no medication)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some treatments for HER2 positive breast cancer can cause heart problems. No treatments are currently available to prevent these problems.</li> <li class="seamTextUnorderedListItem">Carvedilol (Coreg®) is a heart disease medication called a beta blocker.</li> <li class="seamTextUnorderedListItem">Empagliflozin (Jardiance®) is a heart disease medication called a SGLT2 inhibitor.</li> <li class="seamTextUnorderedListItem">These drugs may help prevent heart problems from cancer treatment.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06844669' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coreg.com/' target='_blank'>Waylis Therapeutics: Carvedilol (Coreg®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://patient.boehringer-ingelheim.com/us/products/jardiance/heart-failure/benefits?s_kwcid=AL!6545!3!731073183821!b!!g!!jardiance%20reduced%20ejection&cid=cpc:GoogleAds:EA_JAR-HF_DTC_GADS_US_EN_BRAND_GENERIC_TRAFFIC_BMM_g::Jardiance_HFrEF_b_kwd-jardian' target='_blank'>Boehringer Ingelheim: Empagliflozin (Jardiance®)</a> </li></ul>
1

Carvedilol and Empagliflozin to Prevent Heart Problems During Treatment for People with Stage I-IV HER2+ Breast Cancer

HER2HEART-US: Primary Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy: a Pilot 2x2 Factorial Randomized Controlled Trial
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Nearest Location:
1739 miles
Washington University School of Medicine
Saint Louis, MO

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT06844669

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Phase II

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