Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
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®)
3 other identifiers
interventional
468
1 country
174
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2010
Longer than P75 for phase_2 breast-cancer
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 9, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedResults Posted
Study results publicly available
March 30, 2021
CompletedMarch 30, 2021
April 1, 2019
7.4 years
November 6, 2009
January 12, 2021
March 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment
Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.
2 years
Number of Participants With LVEF Decrease to <50%
Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \<50%
2 years
Secondary Outcomes (3)
Number of Patients With Trastuzumab Course Interruption
2 years
Quality-of-life Changes Between Baseline and 52-weeks
52 weeks
Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline
2 years
Study Arms (3)
Arm I lisinopril
EXPERIMENTALPatients receive oral lisinopril once daily.
Arm II Coreg CR®
EXPERIMENTALPatients receive oral Coreg CR® once daily.
Arm III placebo
PLACEBO COMPARATORPatients receive oral placebo once daily.
Interventions
Given orally
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (174)
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Olive View - UCLA Medical Center Foundation
Sylmar, California, 91342, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
Resurrection Medical Center
Chicago, Illinois, 60631, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Illinois CancerCare - Pekin
Pekin, Illinois, 61603, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, 47403, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, 46237, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Covenant Cancer Treatment Center
Waterloo, Iowa, 50702, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Mercy Hospital
Portland, Maine, 04101, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, 21215, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Jordan Hospital Club Cancer Center
Plymouth, Massachusetts, 02360, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Bay Regional Medical Center
Bay City, Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Singh and Arora Hematology Oncology, PC
Flint, Michigan, 48532, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Great Lakes Cancer Institute - Lapeer Campus
Lapeer, Michigan, 48446, United States
Clemens Regional Medical Center
Mount Clemens, Michigan, 48043, United States
Mercy General Health Partners
Muskegon, Michigan, 49444, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Freeman Cancer Institute
Joplin, Missouri, 64804, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
Foundation Medical Partners
Nashua, New Hampshire, 03060, United States
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, 03060, United States
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395, United States
UMDNJ University Hospital
Newark, New Jersey, 07103, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, 08360, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, 10305, United States
Park Ridge Health
Henderson, North Carolina, 28792, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
CCOP - Dayton
Dayton, Ohio, 45420, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Cancer Care Associates - Norman
Norman, Oklahoma, 73071, United States
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, 73120, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, 19460, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, 18840, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Keyserling Cancer Center at Beaufort Memorial Hospital
Beaufort, South Carolina, 29902, United States
St. Francis Hospital
Greenville, South Carolina, 29601, United States
Gibbs Cancer Center - Pelham
Greer, South Carolina, 29651, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, 22901, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Mercy Regional Cancer Center
Janesville, Wisconsin, 53547, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
D.N. Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
Guglin M, Krischer J, Tamura R, Fink A, Bello-Matricaria L, McCaskill-Stevens W, Munster PN. Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer. J Am Coll Cardiol. 2019 Jun 11;73(22):2859-2868. doi: 10.1016/j.jacc.2019.03.495.
PMID: 31171092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maya Guglin, MD, PhD
- Organization
- University of South Florida
Study Officials
- STUDY CHAIR
Maya Guglin, MD, PhD
University of South Florida
- STUDY CHAIR
Pamela N. Munster, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 9, 2009
Study Start
March 1, 2010
Primary Completion
August 1, 2017
Study Completion
November 1, 2018
Last Updated
March 30, 2021
Results First Posted
March 30, 2021
Record last verified: 2019-04