Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
Primary Purpose
Breast Cancer, Cardiac Toxicity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coreg CR®
lisinopril
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring cardiac toxicity, HER2-positive breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer
Eligibility Criteria
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.
Sites / Locations
- Todd Cancer Institute at Long Beach Memorial Medical Center
- Olive View - UCLA Medical Center Foundation
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- North Colorado Medical Center
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- St. Mary - Corwin Regional Medical Center
- Exempla Lutheran Medical Center
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- CCOP - Mount Sinai Medical Center
- MBCCOP - Medical College of Georgia Cancer Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Illinois CancerCare - Bloomington
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Resurrection Medical Center
- Louis A. Weiss Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Illinois CancerCare - Havana
- Illinois CancerCare - Kewanee Clinic
- La Grange Memorial Hospital
- Illinois CancerCare - Macomb
- Illinois CancerCare - Monmouth
- Good Samaritan Regional Health Center
- Illinois CancerCare - Community Cancer Center
- Advocate Christ Medical Center
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Illinois CancerCare - Pekin
- CCOP - Illinois Oncology Research Association
- Illinois CancerCare - Peru
- Illinois CancerCare - Princeton
- West Suburban Center for Cancer Care
- Regional Cancer Center at Memorial Medical Center
- Bloomington Hospital Regional Cancer Institute
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- St. Francis Hospital Cancer Care Services
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC - La Porte
- Cedar Rapids Oncology Associates
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Covenant Cancer Treatment Center
- Lucille P. Markey Cancer Center at University of Kentucky
- MBCCOP - LSU Health Sciences Center
- Mercy Hospital
- Mercy Medical Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Suburban Hospital
- Jordan Hospital Club Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- Singh and Arora Hematology Oncology, PC
- Butterworth Hospital at Spectrum Health
- Lacks Cancer Center at Saint Mary's Health Care
- West Michigan Cancer Center
- Great Lakes Cancer Institute - Lapeer Campus
- Clemens Regional Medical Center
- Mercy General Health Partners
- Northern Michigan Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- Central Care Cancer Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Goldschmidt Cancer Center
- Freeman Cancer Institute
- Missouri Baptist Cancer Center
- Mercy Hospital St. Louis
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- Big Sky Oncology
- Sletten Cancer Institute at Benefis Healthcare
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Foundation Medical Partners
- Oncology Center at St. Joseph Hospital
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
- Monmouth Medical Center
- UMDNJ University Hospital
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Lovelace Medical Center - Downtown
- Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
- University of New Mexico Cancer Center
- Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Nalitt Cancer Institute at Staten Island University Hospital
- Park Ridge Health
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Aultman Cancer Center at Aultman Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Cancer Care Associates - Norman
- Cancer Care Associates - Mercy Campus
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Cancer Center at Phoenixville Hospital
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Keyserling Cancer Center at Beaufort Memorial Hospital
- St. Francis Hospital
- Gibbs Cancer Center - Pelham
- Rapid City Regional Hospital
- Martha Jefferson Hospital Cancer Care Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- Mercy Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- D.N. Greenwald Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Waukesha Memorial Hospital Regional Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm I lisinopril
Arm II Coreg CR®
Arm III placebo
Arm Description
Patients receive oral lisinopril once daily.
Patients receive oral Coreg CR® once daily.
Patients receive oral placebo once daily.
Outcomes
Primary Outcome Measures
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.
Number of Participants With LVEF Decrease to <50%
Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to <50%
Secondary Outcome Measures
Number of Patients With Trastuzumab Course Interruption
Measure indicates the number of patients who had an interruption of trastuzumab for any reason
Quality-of-life Changes Between Baseline and 52-weeks
Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.
Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline
Number of Participants with cardiotoxicity-free survival at 750 days from baseline
Full Information
NCT ID
NCT01009918
First Posted
November 6, 2009
Last Updated
March 29, 2021
Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01009918
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cardiac Toxicity
Keywords
cardiac toxicity, HER2-positive breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I lisinopril
Arm Type
Experimental
Arm Description
Patients receive oral lisinopril once daily.
Arm Title
Arm II Coreg CR®
Arm Type
Experimental
Arm Description
Patients receive oral Coreg CR® once daily.
Arm Title
Arm III placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily.
Intervention Type
Drug
Intervention Name(s)
Coreg CR®
Other Intervention Name(s)
carvedilol phosphate extended-release
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
lisinopril
Other Intervention Name(s)
Registered Trade names: Prinivil, Tensopril, Zestril, Hipril
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment
Description
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.
Time Frame
2 years
Title
Number of Participants With LVEF Decrease to <50%
Description
Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to <50%
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Patients With Trastuzumab Course Interruption
Description
Measure indicates the number of patients who had an interruption of trastuzumab for any reason
Time Frame
2 years
Title
Quality-of-life Changes Between Baseline and 52-weeks
Description
Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.
Time Frame
52 weeks
Title
Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline
Description
Number of Participants with cardiotoxicity-free survival at 750 days from baseline
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Guglin, MD, PhD
Organizational Affiliation
University of South Florida
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pamela N. Munster, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
Todd Cancer Institute at Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Olive View - UCLA Medical Center Foundation
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Aurora Presbyterian Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
St. Anthony Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
St. Mary - Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
MBCCOP - Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Illinois CancerCare - Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Illinois CancerCare - Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Resurrection Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60631
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Illinois CancerCare - Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Illinois CancerCare - Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
La Grange Memorial Hospital
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Illinois CancerCare - Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Illinois CancerCare - Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Illinois CancerCare - Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2699
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare - Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois CancerCare - Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare - Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Bloomington Hospital Regional Cancer Institute
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - Elkhart
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
St. Francis Hospital Cancer Care Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - South Bend
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Michiana Hematology Oncology PC - Plymouth
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46563
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Michiana Hematology Oncology PC - La Porte
City
Westville
State/Province
Indiana
ZIP/Postal Code
46391
Country
United States
Facility Name
Cedar Rapids Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Covenant Cancer Treatment Center
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Jordan Hospital Club Cancer Center
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Mecosta County Medical Center
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Singh and Arora Hematology Oncology, PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Great Lakes Cancer Institute - Lapeer Campus
City
Lapeer
State/Province
Michigan
ZIP/Postal Code
48446
Country
United States
Facility Name
Clemens Regional Medical Center
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
Mercy General Health Partners
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Providence Cancer Institute at Providence Hospital - Southfield Campus
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Willmar Cancer Center at Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Central Care Cancer Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Saint Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Goldschmidt Cancer Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Freeman Cancer Institute
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-5309
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Good Samaritan Cancer Center at Good Samaritan Hospital
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68848-1990
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Foundation Medical Partners
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Oncology Center at St. Joseph Hospital
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
UMDNJ University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Lovelace Medical Center - Downtown
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Charles R. Wood Cancer Center at Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Nalitt Cancer Institute at Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Park Ridge Health
City
Henderson
State/Province
North Carolina
ZIP/Postal Code
28792
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
United States Air Force Medical Center - Wright-Patterson
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Cancer Care Associates - Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Cancer Care Associates - Mercy Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Geisinger Hazleton Cancer Center
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Joan Karnell Cancer Center at Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Cancer Center at Phoenixville Hospital
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Guthrie Cancer Center at Guthrie Clinic Sayre
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Keyserling Cancer Center at Beaufort Memorial Hospital
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Gibbs Cancer Center - Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Martha Jefferson Hospital Cancer Care Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Mercy Regional Cancer Center
City
Janesville
State/Province
Wisconsin
ZIP/Postal Code
53547
Country
United States
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
D.N. Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Facility Name
Regional Cancer Center at Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31171092
Citation
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.
Results Reference
derived
Learn more about this trial
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
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