Overview

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.