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

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.

PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carvedilol; Lisinopril; Trastuzumab

Criteria

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.