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Clinical Trials (PDQ®)

  • First Published: 11/5/2009
  • Last Modified: 5/19/2012

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Phase II Randomized Study of Lisinopril or Carvedilol Phosphate Extended-Release in Reducing Cardiotoxicity in Women With HER2-Positive Breast Cancer Receiving Adjuvant or Neoadjuvant Trastuzumab

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Lisinopril or Carvedilol Phosphate in Reducing Side Effects in Women With HER2-Positive Breast Cancer Receiving Trastuzumab

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive careActive18 and overNCISCUSF-0806
SCUSF 0806, HLMCC-0806, NCT01009918

Objectives

Primary

  1. To determine if administration of lisinopril or carvedilol phosphate extended-release (compared to placebo) will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in women receiving adjuvant or neoadjuvant trastuzumab for HER2-positive breast cancer.

Secondary

  1. To determine whether patients randomized to receive lisinopril or carvedilol phosphate extended-release have fewer interruptions in trastuzumab therapy due to cardiomyopathy.
  2. To determine changes in quality of life (QOL) in patients treated with these regimens.
  3. To determine the long-term effects of lisinopril and/or carvedilol phosphate extended-release on the prevention of cardiomyopathy and their impact on QOL.
  4. To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity.

Entry Criteria

Disease Characteristics:

  • Diagnosis of HER2-positive breast cancer

  • Scheduled to receive adjuvant or neoadjuvant trastuzumab therapy
    • Anthracycline-containing regimens allowed
    • Patients receive trastuzumab with their chemotherapy allowed for eligibility work-up
    • Taxanes are allowed
    • Trastuzumab therapy may be given with or after primary chemotherapy

  • Hormone receptor status not specified

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior trastuzumab or anthracyclines prior to this chemotherapy regimen
  • No other concurrent angiotensin-converting enzyme (ACE) inhibitors, β-blockers, or digoxin
  • Concurrent participation in other investigational studies allowed

Patient Characteristics:

  • Menopausal status not specified
  • LVEF ≥ 50% by MUGA or ECHO
  • Creatinine ≤ 1.2 mg/dL
  • Sitting systolic BP > 90 mm Hg
  • Pulse ≥ 60 beats/minute
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow capsules
  • No known cardiac history (i.e., heart failure, myocardial infarction, or radiation-induced cardiac dysfunction)
  • No known allergy to either ACE inhibitors or β-blockers
  • No history of bronchial asthma or related bronchospastic conditions
  • No hereditary or idiopathic angioedema
  • No history of severe hypersensitivity reactions to drugs or other causes (e.g., bee stings)

Expected Enrollment

468

Outcomes

Primary Outcome(s)

Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of LVEF

Secondary Outcome(s)

Number of trastuzumab courses completed without interruption
Quality-of-life changes as assessed by EORTC-QLQ-C30 questionnaire at baseline and at the end of treatment
Long-term effects of study drugs as assessed at 18 and 24 months (or 6 and 12 months after completion of trastuzumab therapy)

Outline

This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral lisinopril once daily.

  • Arm II: Patients receive oral carvedilol phosphate extended-release 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.

Trial Contact Information

Trial Lead Organizations

SunCoast CCOP Research Base at the University of South Florida

Maya Guglin, MD, PhD, Protocol chair
Ph: 813-259-0600; 888-663-3488
Pamela Munster, MD, Protocol co-chair
Ph: 415-885-7810; 800-888-8664
Email: Pmunster@medicine.ucsf.edu

Trial Sites

U.S.A.
California
  Grass Valley
 Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
 Clinical Trials Research Nurse
Ph: 530-274-6635
  Long Beach
 Todd Cancer Institute at Long Beach Memorial Medical Center
 Bichlien Nguyen
Ph: 562-933-0900
  Salinas
 Salinas Valley Memorial Hospital
 Laura Stampleman, MD
Ph: 831-755-1701
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Jeffrey Miller, MD
Ph: 207-795-2935
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 Rose Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Anthony Central Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Littleton
 Littleton Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Parker
 Parker Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Connecticut
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong
Ph: 860-358-2050
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
 Washington Cancer Institute at Washington Hospital Center
 Clinical Trials Office - Washington Cancer Institute
Ph: 202-877-8839
Florida
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Clinical Trials Office - Ella Milbank Foshay Cancer Center
Ph: 561-745-5768
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi Venigalla, MD
Ph: 508-368-3168
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Elisa Krill-Jackson, MD
Ph: 305-535-3300
Georgia
  Augusta
 MBCCOP - Medical College of Georgia Cancer Center
 Randall Roberts
Ph: 818-244-4374
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  Bloomington%
 Illinois CancerCare - Bloomington
 Nguyet Le-Lindqwister
Ph: 309-662-2102
  Canton
 Illinois CancerCare - Canton
 Nguyet Le-Lindqwister
Ph: 309-647-5240
  Carthage
 Illinois CancerCare - Carthage
 Nguyet Le-Lindqwister
Ph: 217-357-6877
  Chicago
 Resurrection Medical Center
 Christopher Rose, MD
Ph: 847-965-3200
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-4750
  Eureka
 Illinois CancerCare - Eureka
 Nguyet Le-Lindqwister
Ph: 309-467-2371
  Galesburg
 Illinois CancerCare - Galesburg
 Nguyet Le-Lindqwister
Ph: 309-344-9269
  Havana
 Illinois CancerCare - Havana
 Nguyet Le-Lindqwister
Ph: 309-543-8557
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet Le-Lindqwister
Ph: 309-852-0598
  La Grange
 La Grange Memorial Hospital
 Clinical Trials Office - La Grange Memorial Hospital
Ph: 630-856-7526
  Macomb
 Illinois CancerCare - Macomb
 Nguyet Le-Lindqwister
Ph: 309-833-3503
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet Le-Lindqwister
Ph: 309-734-3141
  Normal
 Illinois CancerCare - Community Cancer Center
 Nguyet Le-Lindqwister
Ph: 309-662-2102
  Oak Lawn
 Advocate Christ Medical Center
 Amar Hamad
Ph: 708-684-8000
  Ottawa
 Oncology Hematology Associates of Central Illinois, PC - Ottawa
 Nguyet Le-Lindqwister
Ph: 815-431-9270
  Pekin
 Illinois CancerCare - Pekin
 Nguyet Le-Lindqwister
Ph: 309-353-0214
  Peoria
 CCOP - Illinois Oncology Research Association
 Nguyet Le-Lindqwister
Ph: 309-243-3605
800-793-2262
  Peru
 Illinois CancerCare - Peru
 Nguyet Le-Lindqwister
Ph: 815-780-3185
  Princeton
 Illinois CancerCare - Princeton
 Nguyet Le-Lindqwister
Ph: 815-875-3010
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Urbana
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard Gross, MD
Ph: 937-832-1093
  Bloomington
 Bloomington Hospital Regional Cancer Institute
 David Lee, MD
Ph: 812-353-2800
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon, MD
Ph: 574-296-6536
 Elkhart General Hospital
 Robin Zon, MD
Ph: 574-296-6536
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon, MD
Ph: 574-296-6536
  Kokomo
 Howard Community Hospital
 Robin Zon, MD
Ph: 574-296-6536
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon, MD
Ph: 574-296-6536
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3019
  Mishawaka
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon, MD
Ph: 574-296-6536
 Saint Joseph Regional Medical Center
 Robin Zon, MD
Ph: 574-296-6536
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon, MD
Ph: 574-296-6536
  Richmond
 Reid Hospital & Health Care Services
 Howard Gross, MD
Ph: 937-832-1093
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon, MD
Ph: 574-296-6536
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon, MD
Ph: 574-296-6536
  Westville
 Michiana Hematology Oncology PC - La Porte
 Robin Zon, MD
Ph: 574-296-6536
Iowa
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Clinical Trials Office - Cedar Rapids Oncology Associates
Ph: 319-363-2690
  Clive
 Medical Oncology and Hematology Associates - West Des Moines
 Robert Behrens
Ph: 515-875-9713
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert Behrens
Ph: 515-244-7586
888-244-6061
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert Behrens
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert Behrens
Ph: 515-643-8740
  Waterloo
 Covenant Cancer Treatment Center
 Clinical Trials Office - Covenant Cancer Treatment Center
Ph: 319-272-2070
Maine
  Portland
 Mercy Hospital
 Roger Inhorn, MD, PhD
Ph: 207-879-3030
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mayer Gorbaty
Ph: 410-601-4734
 Mercy Medical Center
 David Riseberg, MD
Ph: 410-783-5858
Massachusetts
  Plymouth
 Jordan Hospital Club Cancer Center
 James Koomey
Ph: 508-746-2000
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center
Ph: 517-265-0116
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert Padula
Ph: 616-966-8000
  Big Rapids
 Mecosta County Medical Center
 Gilbert Padula
Ph: 231-796-8691
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert Padula
Ph: 616-391-2799
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert Padula
Ph: 616-752-5222
  Kalamazoo
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
  Marquette
 Upper Michigan Cancer Center at Marquette General Hospital
 Clinical Trials Office - Upper Michigan Cancer Center at Marquette General Hospital
Ph: 906-225-3467
  Monroe
 Community Cancer Center of Monroe
 Rex Mowat
Ph: 734-242-7902
  Muskegon
 Mercy General Health Partners
 Gilbert Padula
Ph: 231-672-2000
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon, MD
Ph: 574-296-6536
  Southfield
 Providence Cancer Institute at Providence Hospital - Southfield Campus
 Anibal Drelichman, MD, MPH, FACP
Ph: 313-552-0620
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon, MD
Ph: 574-296-6536
  Traverse City
 Munson Medical Center
 Gilbert Padula
Ph: 231-935-6202
Minnesota
  Brainerd
 St. Joseph's Medical Center
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Burnsville
 Fairview Ridges Hospital
 Joseph Leach
Ph: 952-892-2000
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph Leach
Ph: 763-236-6000
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph Leach
Ph: 763-236-5000
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph Leach
Ph: 651-232-7970
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph Leach
Ph: 952-993-1517
 Park Nicollet Cancer Center
 Joseph Leach
Ph: 952-993-3248
  Saint Paul
 United Hospital
 Joseph Leach
Ph: 651-241-8000
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph Leach
Ph: 952-403-2031
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Stillwater
 Lakeview Hospital
 Joseph Leach
Ph: 651-439-5330
800-423-7212
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph Leach
Ph: 320-231-4650
800-247-1478
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph Leach
Ph: 651-735-7414
Missouri
  Chesterfield
 Saint Luke's Hospital
 Donald Busiek, MD
Ph: 314-205-6737
  Jefferson City
 Goldschmidt Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
  Saint Louis
 Comprehensive Cancer Care, PC
 Alan Lyss, MD
Ph: 314-996-5514
 Missouri Baptist Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
  Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Big Sky Oncology
 Clinical Trial Office - Big Sky Oncology
Ph: 406-731-8217
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Montana Cancer Specialists at Montana Cancer Center
 Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center
Ph: 406-238-6962
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
  Email: cancerhelp@dartmouth.edu
  Nashua
 Foundation Medical Partners
 Marcia Browne, MD
Ph: 781-237-0700
 Oncology Center at St. Joseph Hospital
 Mary Ann Voltz, MD
Ph: 603-880-3408
New Jersey
  Elizabeth
 Trinitas Comprehensive Cancer Center at Trinitas Hospital
 Gerardo Capo
Ph: 908-994-5000
  Long Branch
 Monmouth Medical Center
 Clinical Trials Office - Monmouth Medical Center
Ph: 732-923-7689
  Newark
 UMDNJ University Hospital
 Robert Wieder
Ph: 973-972-4300
  Vineland
 Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
 Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Ph: 856-641-7933
New Mexico
  Albuquerque
 Lovelace Medical Center - Downtown
 Zoneddy Dayao
Ph: 505-727-8000
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Cooperstown
 Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
 Eric Bravin, MD
Ph: 607-547-3336
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital
Ph: 518-926-6700
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther Rehmus, MD
Ph: 330-344-6505
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Bowling Green
 Wood County Oncology Center
 Rex Mowat
Ph: 419-352-9498
  Canton
 Aultman Cancer Center at Aultman Hospital
 Clinical Trials Office - Aultman Cancer Center at Aultman Hospital
Ph: 330-363-6891
  Dayton
 CCOP - Dayton
 Howard Gross, MD
Ph: 937-832-1093
 David L. Rike Cancer Center at Miami Valley Hospital
 Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital
Ph: 937-208-2079
 Samaritan North Cancer Care Center
 Howard Gross, MD
Ph: 937-832-1093
  Elyria
 Community Cancer Center
 Rex Mowat
Ph: 440-324-0400
 Hematology Oncology Center
 Rex Mowat
Ph: 440-324-0401
  Findlay
 Blanchard Valley Medical Associates
 Howard Gross, MD
Ph: 937-832-1093
  Franklin
 Middletown Regional Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Greenville
 Wayne Hospital
 Howard Gross, MD
Ph: 937-832-1093
  Kettering
 Charles F. Kettering Memorial Hospital
 Clinical Trials Office - Charles F. Kettering Memorial Hospital
Ph: 937-298-3399 ext. 57556
  Lima
 Lima Memorial Hospital
 Rex Mowat
Ph: 419-228-3335
  Maumee
 Northwest Ohio Oncology Center
 Rex Mowat
Ph: 419-891-5600
  Oregon
 St. Charles Mercy Hospital
 Rex Mowat
Ph: 419-696-7200
 Toledo Clinic - Oregon
 Rex Mowat
Ph: 419-691-4235
  Sandusky
 North Coast Cancer Care, Incorporated
 Rex Mowat
Ph: 419-626-9090
  Sylvania
 Flower Hospital Cancer Center
 Clinical Trials Office - Flower Hospital Cancer Center
Ph: 419-824-1842
  Tiffin
 Mercy Hospital of Tiffin
 Rex Mowat
Ph: 419-447-3130
  Toledo
 CCOP - Toledo Community Hospital
 Rex Mowat
Ph: 419-843-6147
 Medical University of Ohio Cancer Center
 Clinical Trials Office - Medical University of Ohio Cancer Center
Ph: 419-383-6583
 St. Anne Mercy Hospital
 Rex Mowat
Ph: 419-407-2663
 Toledo Clinic, Incorporated - Main Clinic
 Rex Mowat
Ph: 419-479-5605
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center
Ph: 937-440-4842
  Wauseon
 Fulton County Health Center
 Clinical Trials Office - Fulton County Health Center
Ph: 419-330-2708
  Wright-Patterson Afb
 United States Air Force Medical Center - Wright-Patterson
 Brandon Cutler
Ph: 937-257-9133
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard Gross, MD
Ph: 937-832-1093
Oklahoma
  Norman
 Cancer Care Associates - Norman
 Vikki Canfield, MD
Ph: 405-751-4343
  Oklahoma City
 Cancer Care Associates - Mercy Campus
 Vikki Canfield, MD
Ph: 405-751-4343
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Jihad Khattab
Ph: 918-494-2273
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Harsh Gandhi
Ph: 570-459-2901
  Philadelphia
 Joan Karnell Cancer Center at Pennsylvania Hospital
 Bernard Mason, MD
Ph: 215-829-6088
  Phoenixville
 Cancer Center at Phoenixville Hospital
 Carl Sharer, DO
Ph: 610-983-1800
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Clinical Trials Office - Guthrie Cancer Center at Guthrie Clinic Sayre
Ph: 800-836-0388
  State College
 Geisinger Medical Group - Scenery Park
 Harsh Gandhi
Ph: 814-231-4560
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
South Carolina
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Richard Tenglin
Ph: 605-719-2360
Virginia
  Fredericksburg
 Fredericksburg Oncology, Incorporated
 Rex Mowat
Ph: 540-368-0500
Wisconsin
  Fond du Lac
 Central Wisconsin Cancer Program at Agnesian HealthCare
 Clinical Trials Office - Central Wisconsin Cancer Program at Agnesian HealthCare
Ph: 800-494-2927
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Janesville
 Mercy Regional Cancer Center
 Robert Delaune, MD
Ph: 952-993-1517
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Mukwonago
 D.N. Greenwald Center
 Michael Thompson
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Clinical Trials Office - Regional Cancer Center at Oconomowoc Memorial Hospital
Ph: 262-928-7878
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center
Ph: 262-928-7632

Registry Information
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®)
Trial Start Date 2010-03-01
Trial Completion Date 2013-03-01 (estimated)
Registered in ClinicalTrials.gov NCT01009918
Date Submitted to PDQ 2009-11-04
Information Last Verified 2012-05-19
NCI Grant/Contract Number CA81920

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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