A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging
HER2 Positive Breast Cancer, Cardiovascular Abnormalities
About this trial
This is an interventional prevention trial for HER2 Positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I - III)
- Pathology report must include HER2 expression, estrogen and progesterone receptor status
- Normal LV function (EF > 53%) on baseline echocardiogram
- NYHA functional class I-II (no symptoms, dyspnea with more than 2 blocks)
- Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens
- Patients with a history of HTN, hyperlipidemia, diabetes, mild CAD, mild valvular disease are permitted
- Patients on concomitant cardiac medications other than beta-blockers (BB) or ace-inhibitors (ACE) therapy are permitted. Other non-cardiac medications are not prohibited.
- Women of childbearing potential and sexually active men and women should use effective contraception.
- Patients must have a signed informed consent prior to registration
Exclusion Criteria:
- LV dysfunction (EF < 53%)
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
- Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies)
- Metastatic breast cancer
- Patients who have ever taken BB/ACE therapy are excluded.
- 2nd and 3rd degree AV block
- Sick sinus syndrome
- Patients with severe bradycardia (< 50 bpm) or severe hypotension (SBP < 85 mmHg)
- Severe liver dysfunction defined as Child-Turcotte-Pugh class B & C (significant functional compromise - decompensated disease)
- Moderate-severe Asthma
- Hypersensitivity to beta-blockers
- Patients who are pregnant/lactating are not eligible
- Unwilling to consent/assent to blood donation
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Prophylactic Carvedilol
No Therapy
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.
Standard of care monitoring without prophylactic treatment.