Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01622868
First received: June 15, 2012
Last updated: September 12, 2014
Last verified: June 2014
  Purpose

This randomized phase II trial studies how well whole-brain radiation therapy (WBRT) with or without lapatinib ditosylate works in treating patients with brain metastasis from human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.


Condition Intervention Phase
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Tumors Metastatic to Brain
Drug: lapatinib ditosylate
Radiation: whole-brain radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of RTOG and KROG

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • CR rate in the brain measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on MRI scan of the brain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Response in the brain also will be measured using bidimensional measurements (World Health Organization [WHO]/modified McDonald's criteria).


Secondary Outcome Measures:
  • CR rate in the brain measured using revise RECIST version 1.1 based on MRI scan of the brain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Response in the brain also will be measured using bidimensional measurements (WHO/modified McDonald's criteria).

  • Objective response rate (ORR) (CR + PR) measured using RECIST version 1.1 based on MRI scan of the brain [ Time Frame: At 4 weeks ] [ Designated as safety issue: No ]
  • ORR (CR + PR) measured using RECIST version 1.1 based on MRI scan of the brain [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Lesion-specific ORR (CR + PR) [ Time Frame: At 4 weeks ] [ Designated as safety issue: No ]
  • Lesion-specific ORR (CR + PR) [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]
  • Overall response (CR, PR, or stable disease [SD]) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Treatment-related toxicity as measured by Common Terminology Criterial for Adverse Events version 4 [ Time Frame: Up to 12 weeks post WBRT ] [ Designated as safety issue: Yes ]
  • CNS PFS [ Time Frame: From the time of randomization to the date of first failure (CNS progression or death due to any cause), assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method. Compared between arms using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with PFS.

  • PFS [ Time Frame: From the date of randomization to the date of first failure or last follow-up, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method. Compared between arms using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with PFS.

  • OS [ Time Frame: From the date of randomization to the date of first failure, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated by the Kaplan-Meier method. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with OS.


Estimated Enrollment: 143
Study Start Date: July 2012
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (WBRT)
Patients undergo WBRT QD 5 days a week for 3 weeks.
Radiation: whole-brain radiation therapy
Undergo WBRT
Other Names:
  • WBRT
  • whole-brain radiotherapy
Experimental: Arm II (lapatinib ditosylate, WBRT)
Patients receive lapatinib ditosylate PO QD on days 1-42 and undergo WBRT as in arm I.
Drug: lapatinib ditosylate
Given PO
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb
Radiation: whole-brain radiation therapy
Undergo WBRT
Other Names:
  • WBRT
  • whole-brain radiotherapy

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if there is a signal for an increase in complete response (CR) rate in the brain at 12 weeks post whole-brain radiotherapy (WBRT) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to WBRT compared to WBRT alone.

SECONDARY OBJECTIVES:

I. To evaluate CR rate in the brain at 4 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.

II. To evaluate objective response rate in the brain at 4 and 12 weeks post WBRT as determined by MRI scan of the brain, with the addition of lapatinib to WBRT compared to WBRT alone.

III. To evaluate lesion-specific objective response rate (CR + partial response [PR]) at 4 and 12 weeks post WBRT.

IV. To evaluate overall response with addition of lapatinib to WBRT compared to WBRT alone.

V. To evaluate the central nervous system (CNS) progression-free survival (PFS) rate and overall survival (OS) rate, with the addition of lapatinib to WBRT compared to WBRT alone.

VI. To evaluate treatment-related adverse events when adding lapatinib to WBRT compared to WBRT alone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo WBRT once daily (QD) 5 days a week for 3 weeks.

ARM II: Patients receive lapatinib ditosylate orally (PO) QD on days 1-42 and undergo WBRT as in arm I.

After completion of study treatment, patients are followed up at 4 and 12 weeks and then every 12 weeks thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer
  • HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.2)
  • At least 1 measurable, unirradiated parenchymal brain lesion (>= 10 mm on T1-weighted gadolinium-enhanced MRI) within 21 days prior to study entry; patients may also have the following:

    • Progressive parenchymal brain metastases following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable lesion
    • Progressive parenchymal brain metastases following surgical resection of 1-3 brain metastases, as long as at least 1 brain metastasis is measurable
  • History/physical examination within 21 days prior to study entry
  • Karnofsky performance status >= 60% within 21 days prior to study entry
  • Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)
  • Absolute neutrophil count (ANC) >= 1,200 cells/mm^3
  • Platelets >= 70,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
  • Creatinine < 1.5 times institutional upper limit of normal
  • Bilirubin < 1.5 times institutional upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 times institutional upper limit of normal with or without liver metastasis
  • At least 14 days between FINAL dose of prior chemotherapy and study entry, with recovery of toxicities to grade 0 or 1
  • Patient must provide study specific informed consent prior to study entry
  • Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry
  • Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
    • History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry
  • Grade 2 or greater rash of any cause at time of study entry
  • Grade 2 or greater diarrhea of any cause at time of study entry

Exclusion Criteria:

  • Prior WBRT
  • Prior lapatinib therapy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years
  • Leptomeningeal disease
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion
  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: NCT01622868

  Hide Study Locations
Locations
United States, Alabama
The Kirklin Clinic at Acton Road Recruiting
Birmingham, Alabama, United States, 35243
Contact: Jennifer F. De Los Santos    205-934-0309      
Principal Investigator: Jennifer F. De Los Santos         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jennifer F. De Los Santos    205-934-0309      
Principal Investigator: Jennifer F. De Los Santos         
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: Suzanne M. Russo    251-665-8000    pfrancisco@usouthal.edu   
Principal Investigator: Suzanne M. Russo         
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Active, not recruiting
Auburn, California, United States, 95603
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Active, not recruiting
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center Terminated
Carmichael, California, United States, 95608
Sutter Cancer Centers Radiation Oncology Services-Roseville Active, not recruiting
Roseville, California, United States, 95661
Mercy General Hospital Radiation Oncology Center Terminated
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Withdrawn
Sacramento, California, United States, 95815
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Kathleen C. Horst    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Kathleen C. Horst         
Sutter Cancer Centers Radiation Oncology Services-Vacaville Active, not recruiting
Vacaville, California, United States, 95687
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: Neal B. Goldberg    860-224-5660      
Principal Investigator: Neal B. Goldberg         
United States, Delaware
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Regional Hematology and Oncology PA Recruiting
Newark, Delaware, United States, 19713
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Delaware Clinical and Laboratory Physicians PA Recruiting
Newark, Delaware, United States, 19713
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Christiana Gynecologic Oncology LLC Recruiting
Newark, Delaware, United States, 19713
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Beebe Health Campus Recruiting
Rehoboth Beach, Delaware, United States, 19971
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
Christiana Care Health System-Wilmington Hospital Recruiting
Wilmington, Delaware, United States, 19801
Contact: Adam Raben    302-733-6227      
Principal Investigator: Adam Raben         
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam W. Nowlan    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Northside Hospital-Forsyth Recruiting
Cumming, Georgia, United States, 30041
Contact: Sahar E. Rosenbaum    404-303-3355      
Principal Investigator: Sahar E. Rosenbaum         
Piedmont Fayette Hospital Recruiting
Fayetteville, Georgia, United States, 30214
Contact: Adam W. Nowlan    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Frank G. Lake    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Frank G. Lake         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
Saint Joseph Hospital Recruiting
Chicago, Illinois, United States, 60657
Contact: Nicholas S. Galanopoulos    708-484-8400      
Principal Investigator: Nicholas S. Galanopoulos         
United States, Indiana
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Elkhart General Hospital Terminated
Elkhart, Indiana, United States, 46515
Elkhart Clinic Terminated
Elkhart, Indiana, United States, 46514-2098
Parkview Hospital Randallia Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Radiation Oncology Associates PC Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Brian K. Chang    260-373-8888    parkviewresearch@parkview.com   
Principal Investigator: Brian K. Chang         
Community Howard Regional Health Terminated
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital Terminated
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Saint Joseph Regional Medical Center-Mishawaka Terminated
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
South Bend Clinic Terminated
South Bend, Indiana, United States, 46617
Memorial Hospital of South Bend Terminated
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
United States, Kansas
Saint Luke's South Hospital Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Kansas City CCOP Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur    913-948-5588    amy.krushelniski@hcahealthcare.com   
Principal Investigator: Rakesh Gaur         
United States, Kentucky
Norton Hospital Pavilion and Medical Campus Recruiting
Louisville, Kentucky, United States, 40202
Contact: Aaron C. Spalding    502-629-2500      
Principal Investigator: Aaron C. Spalding         
United States, Massachusetts
Boston Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Bixby Medical Center Terminated
Adrian, Michigan, United States, 49221
Hickman Cancer Center Terminated
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Terminated
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health Big Rapids Hospital Terminated
Big Rapids, Michigan, United States, 49307
Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48124
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Grand Rapids Clinical Oncology Program Terminated
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Mercy Memorial Hospital Terminated
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe Terminated
Monroe, Michigan, United States, 48162
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Lakeland Community Hospital Recruiting
Niles, Michigan, United States, 49120
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Saint John's Hospital - Healtheast Active, not recruiting
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Metro-Minnesota CCOP Terminated
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Paul W. Sperduto    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Paul W. Sperduto         
United States, Mississippi
Singing River Hospital Recruiting
Pascagoula, Mississippi, United States, 39581
Contact: James E. Clarkson    228-809-5292      
Principal Investigator: James E. Clarkson         
United States, Missouri
Cape Radiation Oncology Terminated
Cape Girardeau, Missouri, United States, 63703
Centerpoint Medical Center LLC Recruiting
Independence, Missouri, United States, 64057
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
North Kansas City Hospital Terminated
Kansas City, Missouri, United States, 64116
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Heartland Hematology and Oncology Associates Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Liberty Hospital Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Saint Joseph Oncology Inc Terminated
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Imran Zoberi    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: Imran Zoberi         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint Louis-Cape Girardeau CCOP Withdrawn
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center-South County Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Imran Zoberi    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: Imran Zoberi         
Barnes-Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Imran Zoberi    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: Imran Zoberi         
Siteman Cancer Center - Saint Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Imran Zoberi    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: Imran Zoberi         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, New Hampshire
Elliot Hospital Active, not recruiting
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Benny J. Liem    505-272-6972      
Principal Investigator: Benny J. Liem         
Memorial Medical Center - Las Cruces Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Benny J. Liem    505-272-6972      
Principal Investigator: Benny J. Liem         
United States, New York
Hematology Oncology Associates of Central New York PC-East Syracuse Terminated
East Syracuse, New York, United States, 13057
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Sheryl Green    212-824-7320    jenny.figueroa@mssm.edu   
Principal Investigator: Sheryl Green         
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
United States, North Carolina
Park Ridge Hospital Breast Health Center Recruiting
Hendersonville, North Carolina, United States, 28792
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm    704-873-5661      
Principal Investigator: Ruby A. Grimm         
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchel L. Fromm    330-344-6348      
Principal Investigator: Mitchel L. Fromm         
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Radiation Oncology Center Terminated
Alliance, Ohio, United States, 44601
Summa Barberton Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Cleveland Clinic Cancer Center Beachwood Recruiting
Beachwood, Ohio, United States, 44122
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Toledo Clinic Cancer Centers-Bowling Green Terminated
Bowling Green, Ohio, United States, 43402
Mercy Medical Center Recruiting
Canton, Ohio, United States, 44708
Contact: Edward J. Walsh    888-293-4673      
Principal Investigator: Edward J. Walsh         
Geaugra Hospital Recruiting
Chardon, Ohio, United States, 44024
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
Mercy Cancer Center-Elyria Active, not recruiting
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence Recruiting
Independence, Ohio, United States, 44131
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Lima Memorial Hospital Terminated
Lima, Ohio, United States, 45804
Toledo Clinic Cancer Centers-Maumee Terminated
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Terminated
Maumee, Ohio, United States, 43537
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Summa Health Center at Lake Medina Recruiting
Medina, Ohio, United States, 44256
Contact: Charles A. Kunos    330-375-6101      
Principal Investigator: Charles A. Kunos         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
UHHS-Chagrin Highlands Medical Center Recruiting
Orange Village, Ohio, United States, 44122
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Saint Charles Hospital Terminated
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon Terminated
Oregon, Ohio, United States, 43616
University Hospitals Parma Medical Center Active, not recruiting
Parma, Ohio, United States, 44129
Robinson Radiation Oncology Recruiting
Ravenna, Ohio, United States, 44266
Contact: Mitchel L. Fromm    330-344-6348      
Principal Investigator: Mitchel L. Fromm         
Cancer Care Center, Incorporated Terminated
Salem, Ohio, United States, 44460
North Coast Cancer Care Recruiting
Sandusky, Ohio, United States, 44870
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Cleveland Clinic Cancer Center-Strongsville Recruiting
Strongsville, Ohio, United States, 44136
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Flower Hospital Terminated
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin Terminated
Tiffin, Ohio, United States, 44883
Toledo Clinic Cancer Centers-Toledo Terminated
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center Terminated
Toledo, Ohio, United States, 43608
Mercy Saint Anne Hospital Terminated
Toledo, Ohio, United States, 43623
Toledo Community Hospital Oncology Program CCOP Terminated
Toledo, Ohio, United States, 43617
University of Toledo Terminated
Toledo, Ohio, United States, 43614
Fulton County Health Center Terminated
Wauseon, Ohio, United States, 43567
UHHS-Westlake Medical Center Recruiting
Westlake, Ohio, United States, 44145
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
Cancer Treatment Center Terminated
Wooster, Ohio, United States, 44691
Cleveland Clinic Wooster Specialty Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Simon S. Lo    800-641-2422      
Principal Investigator: Simon S. Lo         
United States, Oklahoma
Natalie Warren Bryant Cancer Center at Saint Francis Terminated
Tulsa, Oklahoma, United States, 74136
Oklahoma Oncology Inc Terminated
Tulsa, Oklahoma, United States, 74104
Warren Cancer Research Foundation Terminated
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Wayne H. Pinover    215-481-2402      
Principal Investigator: Wayne H. Pinover         
Thomas Jefferson University Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Albert Yuen    610-988-9323      
Principal Investigator: Albert Yuen         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer L. Harper    843-792-9321      
Principal Investigator: Jennifer L. Harper         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Upstate Carolina CCOP Terminated
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Richard L. Crownover    210-567-0653    che@uthscsa.edu   
Principal Investigator: Richard L. Crownover         
United States, Virginia
Fredericksburg Oncology Inc Terminated
Fredericksburg, Virginia, United States, 22401
United States, West Virginia
Wheeling Hospital Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jondavid Pollock    304-243-6442      
Principal Investigator: Jondavid Pollock         
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Bethany M. Anderson    877-405-6866      
Principal Investigator: Bethany M. Anderson         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Bethany M. Anderson    877-405-6866      
Principal Investigator: Bethany M. Anderson         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Craig A. Schulz    414-326-2675    clinicaltrials@columbia-stmarys.org   
Principal Investigator: Craig A. Schulz         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Adam D. Currey    414-805-4380      
Principal Investigator: Adam D. Currey         
Columbia Saint Mary's Water Tower Medical Commons Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Craig A. Schulz    414-326-2675    clinicaltrials@columbia-stmarys.org   
Principal Investigator: Craig A. Schulz         
Cancer Center of Western Wisconsin Active, not recruiting
New Richmond, Wisconsin, United States, 54017
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Door County Cancer Center Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: James L. Leenstra    920-433-8889      
Principal Investigator: James L. Leenstra         
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Jeffrey N. Greenspoon    905-387-9495      
Principal Investigator: Jeffrey N. Greenspoon         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Thierry M. Muanza    514-398-1444    penny.chipman@mcgill.ca   
Principal Investigator: Thierry M. Muanza         
Korea, Republic of
Keimyung University-Dongsan Medical Center Active, not recruiting
Jung-Ku, Daegu, Korea, Republic of, 700-712
National Cancer Center-Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Kwan H. Cho    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kwan H. Cho         
Chonnam National University Hwasun Hospital Terminated
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
Samsung Medical Center Active, not recruiting
Seoul, Korea, Korea, Republic of, 135-710
Seoul National University Bundang Hospital Recruiting
Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
Contact: In A. Kim    888-823-5923    ctsucontact@westat.com   
Principal Investigator: In A. Kim         
Yonsei University Health System-Severance Hospital Terminated
Seoul, Korea, Republic of, 120-752
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Jun Won Kim    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Jun Won Kim         
Sponsors and Collaborators
Investigators
Principal Investigator: In Ah Kim Radiation Therapy Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01622868     History of Changes
Other Study ID Numbers: NCI-2012-01977, NCI-2012-01977, CDR0000735353, RTOG 1119, RTOG-1119, U10CA021661
Study First Received: June 15, 2012
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms, Male
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014