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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:March 2010
End Date:November 2018

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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®)

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.

OBJECTIVES:

Primary

- 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.

Secondary

- To determine whether subjects randomized to active agent have fewer interruptions in
trastuzumab therapy due to cardiomyopathy.

- To determine whether the treatment effect is consistent in anthracycline and
nonanthracycline patient cohorts

- To compare changes in HRQL among the treatment groups during the study intervention

- To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL
for either or both study agents

- To compare the predictive value of troponin I and BNP in the identification of
trastuzumab-induced cardiotoxicity

OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy
comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive oral lisinopril once daily.

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

- Arm III: Patients receive oral placebo once daily.

In all arms, study treatment begins with the first dose of trastuzumab and continues for up
to 52 weeks or until the end of trastuzumab therapy.

Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks
(or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the
completion of trastuzumab).

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

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.
We found this trial at
175
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574-335-5000
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1201 Camino de Salud Northeast
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(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2401 West Belvedere Avenue
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(410) 601-4688
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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2600 6th Street Southwest
Canton, Ohio 44710
330-452-9911
Aultman Cancer Center at Aultman Hospital Serving Stark and surrounding counties since 1892, Aultman Hospital...
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100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1240 S Old Dixie Hwy
Jupiter, Florida 33458
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Ella Milbank Foshay Cancer Center at Jupiter Medical Center The Foshay Cancer Center is one...
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200 North Park Street
Kalamazoo, Michigan 49007
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1900 South Avenue
La Crosse, Wisconsin 54601
(608) 782-7300
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One Medical Center Drive
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Augusta, Georgia 30912
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232 S Woods Mill Rd
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1 Wyoming St
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2525 S Downing St
Denver, Colorado 80210
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11600 W 2nd Pl
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
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1221 Pleasant St Suite 100
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411 Laurel St New Visions
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6401 France Ave S
Edina, Minnesota 55435
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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303 S Nappanee St
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600 East Blvd
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
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101 S Major St
Eureka, Illinois 61530
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200 West Pearl Street
Findlay, Ohio 45840
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105 Mcknight Drive
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550 Osborne Road
Fridley, Minnesota 55432
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3315 N. Seminary Street
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Great Falls, Montana 59405
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