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ACTIVE NOT RECRUITING

NCT02993198

PHASE2

A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Study of Early Stage Breast Cancer Patients With Abnormal Myocardial Deformation Treated With Anthracycline and/or Trastuzumab and Pertuzumab-based Cancer Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2015-04

Completion Date

2025-12

Last Updated

2024-06-03

Healthy Volunteers

Conditions

HER2 Positive Breast Cancer Cardiovascular Abnormalities

Interventions

DRUG

Carvedilol

Inclusion Criteria: 1. Patients \> 18 years of age with HER2-overexpressing early stage breast cancer (Stages I - III) 2. Pathology report must include HER2 expression, estrogen and progesterone receptor status 3. Normal LV function (EF \> 53%) on baseline echocardiogram 4. NYHA functional class I-II (no symptoms, dyspnea with more than 2 blocks) 5. Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens 6. Patients with a history of HTN, hyperlipidemia, diabetes, mild CAD, mild valvular disease are permitted 7. Patients on concomitant cardiac medications other than beta-blockers (BB) or ace-inhibitors (ACE) therapy are permitted. Other non-cardiac medications are not prohibited. 8. Women of childbearing potential and sexually active men and women should use effective contraception. 9. Patients must have a signed informed consent prior to registration Exclusion Criteria: 1. LV dysfunction (EF \< 53%) 2. New York Heart Association (NYHA) functional class III-IV (heart failure symptoms at less than 2 blocks to advanced symptoms at rest) a. NYHA Classification: I - No limitations to activity II - Slight limitation to ordinary activity, no symptoms at rest III - Marked limitation to less than ordinary activity, no symptoms at rest IV - Inability to carry out activity without symptoms, symptoms at rest 3. Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies) 4. Metastatic breast cancer 5. Patients who have ever taken BB/ACE therapy are excluded. 6. 2nd and 3rd degree AV block 7. Sick sinus syndrome 8. Patients with severe bradycardia (\< 50 bpm) or severe hypotension (SBP \< 85 mmHg) 9. Severe liver dysfunction defined as Child-Turcotte-Pugh class B \& C (significant functional compromise - decompensated disease) 10. Moderate-severe Asthma 11. Hypersensitivity to beta-blockers 12. Patients who are pregnant/lactating are not eligible 13. Unwilling to consent/assent to blood donation

Locations (1)

Northwestern University

Chicago, Illinois, United States