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SCUSF 0806 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®)

Study Chair: 
Maya Guglin, M.D., Ph.D.
Pamela Munster, M.D.
Status:
Approved by NCI
Activation Date: 3/21/2010
NCT01009918 

Study Objectives

The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant, therapy for HER2 positive breast cancer.

The secondary objectives of this study are to: 

  • Determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy
  • Determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts
  • Compare changes in HRQL among the treatment groups during the study intervention
  • Evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents
  • compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity

Inclusion Criteria:

  • Males and Females 18 years and older 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) greater or equal to 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 of 60 beats/minute or greater
  • 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
  • Able and willing to give informed consent
  • Signed HIPAA compliant research authorization (or equivalent for international sites) to release Personal Health Information to the SunCoast CCOP Research Base.
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.

Link to Abstract [.pdf]

 

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U.S. Department of Health & Human Services National Institutes of Health (NIH) National Cancer Institute