Spots Global Cancer Trial Database for Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
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Trial Identification
Brief Title: Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
Official Title: 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®)
Study ID: NCT01009918
Study Description
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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Todd Cancer Institute at Long Beach Memorial Medical Center, Long Beach, California, United States
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
Illinois CancerCare - Bloomington, Bloomington, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
Resurrection Medical Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Havana, Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic, Kewanee, Illinois, United States
La Grange Memorial Hospital, La Grange, Illinois, United States
Illinois CancerCare - Macomb, Macomb, Illinois, United States
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Illinois CancerCare - Community Cancer Center, Normal, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Illinois CancerCare - Pekin, Pekin, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Illinois CancerCare - Peru, Peru, Illinois, United States
Illinois CancerCare - Princeton, Princeton, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Bloomington Hospital Regional Cancer Institute, Bloomington, Indiana, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
St. Francis Hospital Cancer Care Services, Indianapolis, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Covenant Cancer Treatment Center, Waterloo, Iowa, United States
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Mercy Hospital, Portland, Maine, United States
Mercy Medical Center, Baltimore, Maryland, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Suburban Hospital, Bethesda, Maryland, United States
Jordan Hospital Club Cancer Center, Plymouth, Massachusetts, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Bay Regional Medical Center, Bay City, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Singh and Arora Hematology Oncology, PC, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Great Lakes Cancer Institute - Lapeer Campus, Lapeer, Michigan, United States
Clemens Regional Medical Center, Mount Clemens, Michigan, United States
Mercy General Health Partners, Muskegon, Michigan, United States
Northern Michigan Hospital, Petoskey, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
Central Care Cancer Center, Bolivar, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Freeman Cancer Institute, Joplin, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
Mercy Hospital St. Louis, Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Foundation Medical Partners, Nashua, New Hampshire, United States
Oncology Center at St. Joseph Hospital, Nashua, New Hampshire, United States
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
UMDNJ University Hospital, Newark, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Lovelace Medical Center - Downtown, Albuquerque, New Mexico, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital, Cooperstown, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States
Nalitt Cancer Institute at Staten Island University Hospital, Staten Island, New York, United States
Park Ridge Health, Henderson, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital, Canton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Air Force Base, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Cancer Care Associates - Norman, Norman, Oklahoma, United States
Cancer Care Associates - Mercy Campus, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Cancer Center at Phoenixville Hospital, Phoenixville, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Keyserling Cancer Center at Beaufort Memorial Hospital, Beaufort, South Carolina, United States
St. Francis Hospital, Greenville, South Carolina, United States
Gibbs Cancer Center - Pelham, Greer, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Martha Jefferson Hospital Cancer Care Center, Charlottesville, Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
Mercy Regional Cancer Center, Janesville, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
D.N. Greenwald Center, Mukwonago, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States
Contact Details
Name: Maya Guglin, MD, PhD
Affiliation: University of South Florida
Role: STUDY_CHAIR
Name: Pamela N. Munster, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
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