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

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Cardiac Toxicity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Coreg CR®Given orally

Drug:lisinoprilGiven orally

Other:placeboGiven orally

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm I lisinoprilPatients receive oral lisinopril once daily.

Arm II Coreg CR®Patients receive oral Coreg CR® once daily.

Arm III placeboPatients receive oral placebo once daily.

Study Status

Active, not recruiting

Start Date: March 2010

Completed Date:

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of LVEF

Secondary Outcome: Number of trastuzumab courses completed without interruption

Study sponsors, principal investigator, and references

Principal Investigator: Maya Guglin, MD, PhD

Lead Sponsor: University of South Florida

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01009918

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