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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01009918
First received: November 6, 2009
Last updated: January 9, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cardiac Toxicity
Drug: Coreg CR®
Drug: lisinopril
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
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®)

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of LVEF [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of the LVEF of each treatment group with the placebo arm [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of trastuzumab courses completed without interruption [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality-of-life changes as assessed by EORTC-QLQ-C30 questionnaire at baseline and at the end of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Long-term effects of study drugs as assessed at 18 and 24 months (or 6 and 12 months after completion of trastuzumab therapy) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 468
Study Start Date: March 2010
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I lisinopril
Patients receive oral lisinopril once daily.
Drug: lisinopril
Given orally
Other Name: Registered Trade names: Prinivil, Tensopril, Zestril, Hipril
Experimental: Arm II Coreg CR®
Patients receive oral Coreg CR® once daily.
Drug: Coreg CR®
Given orally
Other Name: carvedilol phosphate extended-release
Placebo Comparator: Arm III placebo
Patients receive oral placebo once daily.
Other: placebo
Given orally

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009918

  Hide Study Locations
Locations
United States, California
Todd Cancer Institute at Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Bichlien Nguyen    562-933-0900      
Olive View - UCLA Medical Center Foundation Recruiting
Sylmar, California, United States, 91342
Contact: Nancy R. Feldman    818-364-3686      
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital    303-938-5253      
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen    303-839-6000      
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center    303-403-3605      
United States, Florida
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center    561-745-5768      
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi L. Venigalla, MD    508-368-3168      
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Elisa Krill-Jackson, MD    305-535-3300      
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Randall F. Roberts    818-244-4374      
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Mark A. Taylor, MD    912-354-6187      
United States, Illinois
Illinois CancerCare - Bloomington Recruiting
Bloomington%, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-6877      
Louis A. Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Clinical Trials Office - Louis A. Weiss Memorial Hospital    773-564-5044      
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Christopher G. Rose, MD    847-965-3200      
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Illinois CancerCare - Havana Recruiting
Havana, Illinois, United States, 62644
Contact: Nguyet A. Le-Lindqwister    309-543-8557      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    309-852-0598      
La Grange Memorial Hospital Recruiting
La Grange, Illinois, United States, 60525
Contact: Clinical Trials Office - La Grange Memorial Hospital    630-856-7526      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-3503      
Illinois CancerCare - Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453-2699
Contact: Amar Hamad    708-684-8000      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-431-9270      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    309-353-0214      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-780-3185      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    815-875-3010      
West Suburban Center for Cancer Care Recruiting
River Forest, Illinois, United States, 60305
Contact: Isoken Koko    708-763-2700      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
United States, Indiana
Bloomington Hospital Regional Cancer Institute Recruiting
Bloomington, Indiana, United States, 47403
Contact: David Y. Lee, MD    812-353-2800      
Michiana Hematology-Oncology, PC - Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, MD    574-296-6536      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Robin Zon, MD    574-296-6536      
Elkhart Clinic, LLC Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Robin Zon, MD    574-296-6536      
St. Francis Hospital Cancer Care Services Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Howard M. Gross, MD    937-832-1093      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Robin Zon, MD    574-296-6536      
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Robin Zon, MD    574-296-6536      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology Oncology PC - Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Robin Zon, MD    574-296-6536      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology Oncology PC - La Porte Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon, MD    574-296-6536      
United States, Iowa
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Clinical Trials Office - Cedar Rapids Oncology Associates    319-363-2690      
Medical Oncology and Hematology Associates - West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    515-875-9713      
Medical Oncology and Hematology Associates at Mercy Cancer Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    515-643-8740      
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-282-2921      
CCOP - Iowa Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-244-7586      
Covenant Cancer Treatment Center Recruiting
Waterloo, Iowa, United States, 50702
Contact: Clinical Trials Office - Covenant Cancer Treatment Center    319-272-2070      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
United States, Louisiana
MBCCOP - LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith    504-568-5151      
United States, Maine
Mercy Hospital Recruiting
Portland, Maine, United States, 04101
Contact: Roger C. Inhorn, MD, PhD    207-879-3030      
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Mayer Gorbaty    410-601-4734      
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: David A. Riseberg, MD    410-783-5858      
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Carolyn B. Hendricks, MD    301-897-1503      
United States, Massachusetts
Jordan Hospital Club Cancer Center Recruiting
Plymouth, Massachusetts, United States, 02360
Contact: James M. Koomey    508-746-2000      
United States, Michigan
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D Padula    616-966-8000      
Bay Regional Medical Center Recruiting
Bay City, Michigan, United States, 48708
Contact: Clinical Trials Office - Bay Regional Medical Center    989-667-6257      
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D Padula    231-796-8691      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
Singh and Arora Hematology Oncology, PC Recruiting
Flint, Michigan, United States, 48532
Contact: Justin F. Klamerus    810-235-8568      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-391-2799      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D Padula    616-752-5222      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Great Lakes Cancer Institute - Lapeer Campus Recruiting
Lapeer, Michigan, United States, 48446
Contact: Justin F. Klamerus    810-667-5859      
Clemens Regional Medical Center Recruiting
Mount Clemens, Michigan, United States, 48043
Contact: Clinical Trials Office - Ted B. Wahby Cancer Center at Mount C    586-493-3426      
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D Padula    231-672-2000      
Northern Michigan Hospital Recruiting
Petoskey, Michigan, United States, 49770
Contact: Justin F. Klamerus    231-487-4000      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD    574-296-6536      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD    574-296-6536      
Providence Cancer Institute at Providence Hospital - Southfield Campus Recruiting
Southfield, Michigan, United States, 48075
Contact: Anibal Drelichman, MD MPH FACP    313-552-0620      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D Padula    231-935-6202      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Joseph W. Leach    952-892-2000      
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Joseph W. Leach    763-236-6000      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Joseph W. Leach    763-236-5000      
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Joseph W. Leach    320-234-5000      
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    651-232-7970      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn    612-873-5911      
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor    763-520-1893      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-3248      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Joseph W. Leach    651-241-8000      
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Joseph W. Leach    952-403-2031      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Joseph W. Leach    651-439-5330      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Joseph W. Leach    952-442-2191      
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Joseph W. Leach    320-231-4650      
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Joseph W. Leach    651-735-7414      
United States, Missouri
Central Care Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay Carlson, DO    417-326-7200      
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Alan P. Lyss, MD    314-996-5514      
Saint Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Donald F. Busiek, MD    314-205-6737      
Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan P. Lyss, MD    314-996-5514      
Freeman Cancer Institute Recruiting
Joplin, Missouri, United States, 64804
Contact: Lois Crockett, RN,BSN,CCRP    417-347-4030      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD    314-996-5514      
United States, Montana
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
Big Sky Oncology Recruiting
Great Falls, Montana, United States, 59405-5309
Contact: Clinical Trial Office - Big Sky Oncology    406-731-8217      
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana    406-238-6962      
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital Recruiting
Kearney, Nebraska, United States, 68848-1990
Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good    308-865-7963      
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
Foundation Medical Partners Recruiting
Nashua, New Hampshire, United States, 03060
Contact: Marcia J. Browne, MD    781-237-0700      
Oncology Center at St. Joseph Hospital Recruiting
Nashua, New Hampshire, United States, 03060
Contact: Mary Ann Voltz, MD    603-880-3408      
United States, New Jersey
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Clinical Trials Office - Dizzy Gillespie Cancer Institute at E    201-894-3456      
Monmouth Medical Center Recruiting
Long Branch, New Jersey, United States, 07740-6395
Contact: Clinical Trials Office - Monmouth Medical Center    732-923-7689      
UMDNJ University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Robert Wieder    973-972-4300      
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Recruiting
Vineland, New Jersey, United States, 08360
Contact: Clinical Trials Office - Franklin & Edith Scarpa Regional Canc    856-641-7933      
United States, New Mexico
Lovelace Medical Center - Downtown Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Zoneddy R. Dayao    505-727-8000      
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Jane M. Kanowitz    505-291-2462      
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente    505-272-6972      
United States, New York
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Recruiting
Cooperstown, New York, United States, 13326
Contact: Eric Bravin, MD    607-547-3336      
Charles R. Wood Cancer Center at Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen    518-926-6700      
Nalitt Cancer Institute at Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Qun Dai    718-226-6400      
United States, North Carolina
Park Ridge Health Recruiting
Henderson, North Carolina, United States, 28792
Contact: Mikhail Vindgradov, MD    828-681-2917      
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Esther H. Rehmus, MD    330-344-6505      
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Aultman Cancer Center at Aultman Hospital Recruiting
Canton, Ohio, United States, 44710-1799
Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp    330-363-6891      
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext 57556      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
United States Air Force Medical Center - Wright-Patterson Recruiting
Wright-Patterson Afb, Ohio, United States, 45433-5529
Contact: Brandon J. Cutler    937-257-9133      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
United States, Oklahoma
Cancer Care Associates - Norman Recruiting
Norman, Oklahoma, United States, 73071
Contact: Vikki A. Canfield, MD    405-751-4343      
Cancer Care Associates - Mercy Campus Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Vikki A. Canfield, MD    405-751-4343      
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Jihad Khattab    918-494-2273      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Harsh Gandhi    570-459-2901      
Joan Karnell Cancer Center at Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Lee Hartner    215-829-3000      
Cancer Center at Phoenixville Hospital Recruiting
Phoenixville, Pennsylvania, United States, 19460
Contact: Carl W. Sharer, DO    610-983-1800      
Guthrie Cancer Center at Guthrie Clinic Sayre Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Clinical Trials Office - Guthrie Cancer Center at Guthrie Clin    800-836-0388      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Harsh Gandhi    814-231-4560      
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce    570-271-5251      
United States, South Carolina
Keyserling Cancer Center at Beaufort Memorial Hospital Recruiting
Beaufort, South Carolina, United States, 29902
Contact: Majd Chahin    877-532-6472      
St. Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Amarintha Curtis, MD    864-546-3699      
Contact: Melissa Seman    864-255-1517      
Gibbs Cancer Center - Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Amaninthia Curtis, MD    864-560-6812      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Richard C. Tenglin    605-719-2360      
United States, Virginia
Martha Jefferson Hospital Cancer Care Center Recruiting
Charlottesville, Virginia, United States, 22901
Contact: Robert S. Pritchard, MD    434-982-8390      
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Gerald K. Bayer, MD    920-432-6049      
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gerald K. Bayer, MD    920-432-6049      
Mercy Regional Cancer Center Recruiting
Janesville, Wisconsin, United States, 53547
Contact: Robert Delaune, MD    952-993-1517      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
D.N. Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Michael A. Thompson    262-363-1916      
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc    262-928-7878      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Maya Guglin, MD, PhD University of South Florida
Study Chair: Pamela N. Munster, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01009918     History of Changes
Other Study ID Numbers: SCUSF 0806, SCUSF-0806, 5U10CA081920-11
Study First Received: November 6, 2009
Last Updated: January 9, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of South Florida:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carvedilol
Lisinopril
Trastuzumab
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014