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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 Hospital Bethesda, Maryland  20814
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Rapid City Regional Hospital Rapid City, South Dakota  57709
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Dayton Kettering, Ohio  45429
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
UMDNJ University Hospital Newark, New Jersey  07103
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
Advocate Christ Medical Center Oak Lawn, Illinois  60453
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Northern Michigan Hospital Petoskey, Michigan  49770
Munson Medical Center Traverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
Kalispell Regional Medical Center Kalispell, Montana  59901
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach, California  90801
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls, New York  12801
Samaritan North Cancer Care Center Dayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Saint Luke's Hospital Chesterfield, Missouri  63017
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah, Georgia  31405
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Reid Hospital & Health Care Services Richmond, Indiana  47374
Covenant Cancer Treatment Center Waterloo, Iowa  50702
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Wayne Hospital Greenville, Ohio  45331
Cancer Care Associates - Mercy Campus Oklahoma City, Oklahoma  73120
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre, Pennsylvania  18840
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center Englewood, New Jersey  07631
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Resurrection Medical Center Chicago, Illinois  60631
Jordan Hospital Club Cancer Center Plymouth, Massachusetts  02360
Nalitt Cancer Institute at Staten Island University Hospital Staten Island, New York  10305
La Grange Memorial Hospital La Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Galesburg Clinic, PC Galesburg, Illinois  61401
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Mercy General Health Partners Muskegon, Michigan  49443
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Olive View - UCLA Medical Center Foundation Sylmar, California  91342
Oncology Center at St. Joseph Hospital Nashua, New Hampshire  03060
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Mercy Medical Center Baltimore, Maryland  21202
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown, New York  13326
Foundation Medical Partners Nashua, New Hampshire  03060
Keyserling Cancer Center at Beaufort Memorial Hospital Beaufort, South Carolina  29902
Clemens Regional Medical Center Mount Clemens, Michigan  48043
Southeast Cancer Center Cape Girardeau, Missouri  63703
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Albuquerque, New Mexico  87110
Cancer Care Associates - Norman Norman, Oklahoma  73071
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
Mercy Hospital Portland, Maine  04101
Bloomington Hospital Regional Cancer Institute Bloomington, Indiana  47403
St. Francis Hospital Cancer Care Services Indianapolis, Indiana  46237
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Singh and Arora Hematology Oncology, PC Flint, Michigan  48532
Great Lakes Cancer Institute - Lapeer Campus Lapeer, Michigan  48446