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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer, Cardiac Toxicity

In brief

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.

Key facts

Study ID

NCT01009918

Run by

University of South Florida

People needed

468

Starts

2010-03-01

Expected to finish

2018-11-01

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Olive View - UCLA Medical Center Foundation — Sylmar, California, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Parker Adventist Hospital — Parker, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Ella Milbank Foshay Cancer Center at Jupiter Medical Center — Jupiter, Florida, United States
• Lakeland Regional Cancer Center at Lakeland Regional Medical Center — Lakeland, Florida, United States
• CCOP - Mount Sinai Medical Center — Miami Beach, Florida, United States
• MBCCOP - Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler — Savannah, Georgia, United States
• Todd Cancer Institute at Long Beach Memorial Medical Center — Long Beach, California, United States

Full record on ClinicalTrials.gov

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