HLMCC0806: Breast Cancer
HLMCC0806: Phase II Placebo-Controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients with Breast Cancer Receiving (Neo)Adjuvant Chemotherapy with Trastuzumab (Herceptin®)
Approval Date: 12/31/1969
Principal Investigator: Dana Zakalik, M.D.
The purpose of this study is to compare the effects of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR®) on heart function during treatment with trastuzumab (Herceptin®), a drug given as treatment for breast cancer. Lisinopril and Coreg CR® are used to treat high blood pressure and heart failure in heart attack patients. Study doctors want to find out which medication (lisinopril or Coreg CR®) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active drug. Patients will only get one of the study medicines – either lisinopril, Coreg CR® or placebo. Study patients will keep a log of their use of the study drug, complete 4 quality of life questionnaires and monitor their blood pressure with a study supplied blood pressure cuff.
- Females with HER2 positive breast cancer
- ≥ 18 years of age
- Scheduled to receive trastuzumab (Herceptin®)
- No current use of ACE inhibitors, beta-blockers, statins, digoxin or furosemide
- No history of cardiac disease, bronchial asthma
Status of Clinical Trial:
open and enrolling