Carvedilol for Heart Protection in Breast Cancer Patients

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The Cardio-Oncology program at Northwestern offers care to cancer patients who develop cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2 necessitate treatment with anthracycline and/or trastuzumab and pertuzumab-based chemotherapies, which are known to cause cardiac toxicities. Breast cancer patients will undergo a "cardio-oncology echocardiogram" which incorporates advanced left ventricular assessment by utilizing deformation or strain imaging during chemotherapy treatment for surveillance of cardiac toxicities. The aims of this project are: 1. To create a registry of both clinical, and echocardiographic variables, biomarkers, and genetic analysis that will be used to develop a risk model to predict LV dysfunction in early stage breast cancer patients undergoing chemotherapy with anthracycline and/or trastuzumab and pertuzumab-based chemotherapy regimens. 2. To propose a new management algorithm for initiation of prophylactic beta-blocker therapy for early stage breast cancer patients with preclinical cardiac toxicities demonstrated by strain parameters. 3. To determine if initiation of prophylactic beta-blocker therapy in patients with early cardiac toxicity can delay or prevent a drop in LV EF and the development of clinical heart failure. 4. To explore serial measurements of a suite of novel biomarkers during ongoing anticancer treatment that are presumed but not yet proven to be predictive of cardiac dysfunction in women with breast cancer. 5. To identify DNA biomarkers of predilection to cardiotoxicity. 6. To generate hiPSC to validate markers predictive of cardiotoxicity.

Eligibility Criteria

This trial is for women over 18 with early-stage HER2-positive breast cancer (Stages I-III) who are about to start treatment with specific chemotherapies known to affect the heart. They must have normal heart function and agree to use contraception. Excluded are those with severe pre-existing heart conditions, certain other health issues like severe asthma or liver dysfunction, pregnant/breastfeeding women, and anyone previously on beta-blockers.

Inclusion Criteria

Patients must have a signed informed consent prior to registration

I have a history of high blood pressure, high cholesterol, diabetes, or mild heart issues.

Women of childbearing potential and sexually active men and women should use effective contraception

+6 more

Exclusion Criteria

I have never taken BB/ACE therapy.

Patients who are pregnant/lactating are not eligible

My breast cancer has spread to other parts of my body.

+10 more

Participant Groups

The study tests whether Carvedilol, a beta-blocker medication, can prevent or delay heart damage in patients receiving chemotherapy that's tough on the heart. Patients' hearts will be monitored using advanced imaging techniques to detect early signs of strain or damage during their cancer treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic CarvedilolExperimental Treatment1 Intervention

Carvedilol 3.125 mg by mouth every 12 hours, titrated to a max dose of 25 mg by mouth every 12 hours, depending on blood pressure and heart rate, until completion of study.

Group II: No TherapyActive Control1 Intervention

Standard of care monitoring without prophylactic treatment.