Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab

INCLUSION CRITERIA

Males and Females ≥ 18 years old diagnosed with HER2 positive breast cancer
Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.
Left Ventricular Ejection Fraction (LVEF) ≥ 50% by MUGA scan or echocardiogram
Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.
Sitting systolic blood pressure of > 90 mm Hg
Pulse ≥ 60 beats/minute
Not pregnant or breastfeeding
Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study
Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents
Able to swallow capsules

EXCLUSION CRITERIA:

Patients with metastatic disease
Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen
Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin
Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction
Known allergy to either ACE inhibitors or β-blockers
History of bronchial asthma or related bronchospastic conditions
Hereditary or idiopathic angioedema
History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings
This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.