Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
This study is currently recruiting participants.
Verified January 2013 by University of South Florida
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01009918
First received: November 6, 2009
Last updated: May 20, 2013
Last verified: January 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009918
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| 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. Joseph Hospital | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020 ext 2261 | |
| CCOP - Colorado Cancer Research Program | Recruiting |
| Denver, Colorado, United States, 80222 | |
| 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 | |
| St. Anthony Central Hospital | Recruiting |
| Denver, Colorado, United States, 80204 | |
| 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 | |
| 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 Clinic, LLC | Recruiting |
| Elkhart, Indiana, United States, 46514-2098 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Elkhart General Hospital | Recruiting |
| Elkhart, Indiana, United States, 46515 | |
| 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 | |
| Saint Joseph Regional Medical Center | Recruiting |
| Mishawaka, Indiana, United States, 46545-1470 | |
| 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 | |
| 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 | |
| CCOP - Iowa Oncology Research Association | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-244-7586 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Robert J. Behrens 515-282-2921 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Robert J. Behrens 515-643-8740 | |
| 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 | |
| Lacks Cancer Center at Saint Mary's Health Care | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Gilbert D Padula 616-752-5222 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Gilbert D. Padula 616-391-2799 | |
| 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 | |
| Lakeland Regional Cancer Care Center - St. Joseph | Recruiting |
| Saint Joseph, Michigan, United States, 49085 | |
| Contact: Robin Zon, MD 574-296-6536 | |
| Lakeside Cancer Specialists, PLLC | 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 | |
| Hennepin County Medical Center - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Clinical Trials Office - Hennepin County Medical Center - Minn 612-873-5911 | |
| 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 | |
| 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 | |
| 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 | |
| Missouri Baptist Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63131 | |
| Contact: Alan P. Lyss, MD 314-996-5514 | |
| United States, Montana | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Recruiting |
| Billings, Montana, United States, 59102 | |
| 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 | |
| CCOP - Montana Cancer Consortium | Recruiting |
| Billings, Montana, United States, 59101 | |
| 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 | |
| Sletten Cancer Institute at Benefis Healthcare | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| 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 | |
| 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, Ohio | |
| 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 | |
| McDowell Cancer Center at Akron General Medical Center | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Esther H. Rehmus, MD 330-344-6505 | |
| 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 | |
| CCOP - Dayton | Recruiting |
| Dayton, Ohio, United States, 45420 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| 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 | |
| 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 | |
| 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. Mary's Hospital | Recruiting |
| Green Bay, Wisconsin, United States, 54303 | |
| Contact: Gerald K. Bayer, MD 920-432-6049 | |
| 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 | |
| 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: | May 20, 2013 |
| 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 May 21, 2013