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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®)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Cardiac Toxicity

Thank you

Trial Information

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®)


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Maya Guglin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of South Florida

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0806

NCT ID:

NCT01009918

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cardiac Toxicity
  • 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
  • Breast Neoplasms

Name

Location

Suburban HospitalBethesda, Maryland  20814
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Rapid City Regional HospitalRapid City, South Dakota  57709
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - DaytonKettering, Ohio  45429
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
UMDNJ University HospitalNewark, New Jersey  07103
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
Kalispell Regional Medical CenterKalispell, Montana  59901
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Samaritan North Cancer Care CenterDayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Saint Luke's HospitalChesterfield, Missouri  63017
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Covenant Cancer Treatment CenterWaterloo, Iowa  50702
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Wayne HospitalGreenville, Ohio  45331
Cancer Care Associates - Mercy CampusOklahoma City, Oklahoma  73120
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Guthrie Cancer Center at Guthrie Clinic SayreSayre, Pennsylvania  18840
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical CenterEnglewood, New Jersey  07631
Martha Jefferson Hospital Cancer Care CenterCharlottesville, Virginia  22901
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Resurrection Medical CenterChicago, Illinois  60631
Jordan Hospital Club Cancer CenterPlymouth, Massachusetts  02360
Nalitt Cancer Institute at Staten Island University HospitalStaten Island, New York  10305
La Grange Memorial HospitalLa Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Cancer Center at Phoenixville HospitalPhoenixville, Pennsylvania  19460
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Mercy General Health PartnersMuskegon, Michigan  49443
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Olive View - UCLA Medical Center FoundationSylmar, California  91342
Oncology Center at St. Joseph HospitalNashua, New Hampshire  03060
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Mercy Regional Cancer CenterJanesville, Wisconsin  53547
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Mercy Medical CenterBaltimore, Maryland  21202
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett HospitalCooperstown, New York  13326
Foundation Medical PartnersNashua, New Hampshire  03060
Keyserling Cancer Center at Beaufort Memorial HospitalBeaufort, South Carolina  29902
Clemens Regional Medical CenterMount Clemens, Michigan  48043
Southeast Cancer CenterCape Girardeau, Missouri  63703
Goldschmidt Cancer CenterJefferson City, Missouri  65109
Presbyterian Cancer Treatment Center at Presbyterian Kaseman HospitalAlbuquerque, New Mexico  87110
Cancer Care Associates - NormanNorman, Oklahoma  73071
Littleton Adventist HospitalLittleton, Colorado  80122
Parker Adventist HospitalParker, Colorado  80138
Mercy HospitalPortland, Maine  04101
Bloomington Hospital Regional Cancer InstituteBloomington, Indiana  47403
St. Francis Hospital Cancer Care ServicesIndianapolis, Indiana  46237
D.N. Greenwald CenterMukwonago, Wisconsin  53149
Singh and Arora Hematology Oncology, PCFlint, Michigan  48532
Great Lakes Cancer Institute - Lapeer CampusLapeer, Michigan  48446