Whole-Brain Radiation Therapy or Stereotactic Radiosurgery 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 May 2016 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: July 22, 2016
Last verified: May 2016
  Purpose
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. 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 whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.

Condition Intervention Phase
HER2 Positive Breast Carcinoma
Invasive Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Radiation: Stereotactic Radiosurgery
Radiation: Whole-Brain Radiotherapy
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/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology 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:
  • 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 6 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.

  • CR rate in the brain measured using revised 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).

  • Development of new CNS lesions outside the SRS field [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Incidence of treatment-related toxicity as measured by Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 12 weeks post WBRT ] [ Designated as safety issue: Yes ]
  • 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 ]
  • 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 ]
  • OS [ Time Frame: From the date of randomization to the date of first failure, assessed up to 6 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.

  • Overall response (CR, PR, or stable disease [SD]) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: From the date of randomization to the date of first failure or last follow-up, assessed up to 6 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.


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 A (WBRT or SRS)
Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.
Other: Laboratory Biomarker Analysis
Correlative studies
Radiation: Stereotactic Radiosurgery
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
Radiation: Whole-Brain Radiotherapy
Undergo WBRT
Other Names:
  • WBRT
  • whole-brain radiation therapy
Experimental: Arm B (lapatinib ditosylate, WBRT or SRS)
Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate PO QD for 6 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Lapatinib Ditosylate
Given PO
Other Name: Tykerb
Radiation: Stereotactic Radiosurgery
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
Radiation: Whole-Brain Radiotherapy
Undergo WBRT
Other Names:
  • WBRT
  • whole-brain radiation therapy

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) and within the lesion for stereotactic radiosurgery (SRS) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to WBRT/SRS compared to WBRT/SRS alone.

SECONDARY OBJECTIVES:

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

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

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

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

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

VII. To evaluate development of new CNS lesions outside the SRS field when adding lapatinib to SRS compared to SRS alone.

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

ARM A: Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments or SRS for 1 treatment.

ARM B: Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate orally (PO) once daily (QD) for 6 weeks.

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   (Adult, Senior)
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] >= 2.0)
  • At least 1 measurable and no more than 10, unirradiated parenchymal brain metastasis within 21 days prior to study entry; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:

    • For a single solitary lesion the size must be >= 10 mm
    • For 2 or more lesions, the size of at least 2 of the lesions must be >= 5 mm
    • Patients may also have the following provided the size requirements above are met:

      • Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion
      • Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion
  • 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
  • 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
  • Prior lapatinib is allowed as long as the last dose received was > 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis

Exclusion Criteria:

  • Prior WBRT
  • Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day
  • 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
  • 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
  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
University of Alabama at Birmingham Cancer Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jennifer F. De Los Santos    800-828-8816      
Principal Investigator: Jennifer F. De Los Santos         
The Kirklin Clinic at Acton Road Recruiting
Birmingham, Alabama, United States, 35243
Contact: Jennifer F. De Los Santos    800-828-8816      
Principal Investigator: Jennifer F. De Los Santos         
University of South Alabama Mitchell Cancer Institute Suspended
Mobile, Alabama, United States, 36688
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman    877-602-4111      
Principal Investigator: David G. Brachman         
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Victor J. Gonzalez    520-626-9008      
Principal Investigator: Victor J. Gonzalez         
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn Suspended
Auburn, California, United States, 95603
Sutter Auburn Faith Hospital Suspended
Auburn, California, United States, 95602
Alta Bates Summit Medical Center-Herrick Campus Active, not recruiting
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals Active, not recruiting
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Suspended
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center Active, not recruiting
Carmichael, California, United States, 95608
Sutter Davis Hospital Suspended
Davis, California, United States, 95616
Memorial Medical Center Active, not recruiting
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division Active, not recruiting
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology Active, not recruiting
Mountain View, California, United States, 94040
Palo Alto Medical Foundation Health Care Active, not recruiting
Palo Alto, California, United States, 94301
Stanford Cancer Institute Active, not recruiting
Palo Alto, California, United States, 94304
Sutter Cancer Centers Radiation Oncology Services-Roseville Suspended
Roseville, California, United States, 95661
Sutter Roseville Medical Center Suspended
Roseville, California, United States, 95661
Radiological Associates of Sacramento Withdrawn
Sacramento, California, United States, 95815
Sutter General Hospital Suspended
Sacramento, California, United States, 95816
Mercy General Hospital Radiation Oncology Center Terminated
Sacramento, California, United States, 95819
California Pacific Medical Center-Pacific Campus Suspended
San Francisco, California, United States, 94115
Palo Alto Medical Foundation-Santa Cruz Active, not recruiting
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation Active, not recruiting
Santa Rosa, California, United States, 95403
Palo Alto Medical Foundation-Sunnyvale Active, not recruiting
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville Suspended
Vacaville, California, United States, 95687
Sutter Solano Medical Center/Cancer Center Active, not recruiting
Vallejo, California, United States, 94589
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis Active, not recruiting
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut Suspended
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center Active, not recruiting
Lewes, Delaware, United States, 19958
Christiana Gynecologic Oncology LLC Active, not recruiting
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA Active, not recruiting
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center Active, not recruiting
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA Active, not recruiting
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA Active, not recruiting
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital Active, not recruiting
Newark, Delaware, United States, 19718
Beebe Health Campus Active, not recruiting
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital Active, not recruiting
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital Active, not recruiting
Wilmington, Delaware, United States, 19801
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach Suspended
Deerfield Beach, Florida, United States, 33442
University of Miami Miller School of Medicine-Sylvester Cancer Center Suspended
Miami, Florida, United States, 33136
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 Terminated
Fayetteville, Georgia, United States, 30214
Northeast Georgia Medical Center Suspended
Gainesville, Georgia, United States, 30501
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Suspended
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Suspended
Boise, Idaho, United States, 83706
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
Presence Saint Joseph Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60657
Contact: Nicholas S. Galanopoulos    773-665-3109      
Principal Investigator: Nicholas S. Galanopoulos         
Good Samaritan Regional Health Center Active, not recruiting
Mount Vernon, Illinois, United States, 62864
United States, Indiana
Elkhart Clinic Terminated
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart Terminated
Elkhart, Indiana, United States, 46514
Elkhart General Hospital Terminated
Elkhart, Indiana, United States, 46515
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
Saint Joseph Regional Medical Center-Mishawaka Terminated
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Mishawaka Suspended
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth Terminated
Plymouth, Indiana, United States, 46563
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
Michiana Hematology Oncology PC-South Bend Terminated
South Bend, Indiana, United States, 46601
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-Westville Terminated
Westville, Indiana, United States, 46391
United States, Iowa
Saint Luke's Hospital Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: Aruna Turaka    319-297-2900      
Principal Investigator: Aruna Turaka         
United States, Kansas
Menorah Medical Center Suspended
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital Suspended
Overland Park, Kansas, United States, 66213
Kansas City NCI Community Oncology Research Program 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 Withdrawn
Louisville, Kentucky, United States, 40202
Norton Suburban Hospital and Medical Campus Withdrawn
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mini J. Elnaggar    888-562-4763      
Principal Investigator: Mini J. Elnaggar         
United States, Maryland
Greater Baltimore Medical Center Suspended
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Boston Medical Center Suspended
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 NCORP Terminated
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital Suspended
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James A. Hayman    800-865-1125      
Principal Investigator: James A. Hayman         
Bronson Battle Creek Suspended
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital Terminated
Big Rapids, Michigan, United States, 49307
Henry Ford Macomb Hospital Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
Beaumont Hospital-Dearborn Suspended
Dearborn, Michigan, United States, 48124
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 Suspended
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49829
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Hurley Medical Center Suspended
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute Suspended
Flint, Michigan, United States, 48503
Spectrum Health at Butterworth Campus Suspended
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's Suspended
Grand Rapids, Michigan, United States, 49503
Cancer Research Consortium of West Michigan NCORP Terminated
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain Suspended
Iron Mountain, Michigan, United States, 49801
Allegiance Health Suspended
Jackson, Michigan, United States, 49201
Borgess Medical Center Suspended
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital Suspended
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center Suspended
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital Suspended
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital Suspended
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital Terminated
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers-Monroe Terminated
Monroe, Michigan, United States, 48162
Mercy Health Mercy Campus Suspended
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital Suspended
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland Suspended
Pontiac, Michigan, United States, 48341
Saint Joseph Mercy Port Huron Terminated
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan Suspended
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center Suspended
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital Suspended
St. Joseph, Michigan, United States, 49085
Munson Medical Center Suspended
Traverse City, Michigan, United States, 49684
Downriver Center for Oncology Recruiting
Trenton, Michigan, United States, 48183
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
Saint John Macomb-Oakland Hospital Suspended
Warren, Michigan, United States, 48093
Henry Ford Medical Center - West Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Eleanor M. Walker    313-916-1784      
Principal Investigator: Eleanor M. Walker         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
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: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Health Partners Inc Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Metro Minnesota Community Oncology Research Consortium Terminated
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Srinivasan Vijayakumar    601-815-6700      
Principal Investigator: Srinivasan Vijayakumar         
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
Barnes-Jewish West County Hospital Suspended
Creve Coeur, Missouri, United States, 63141
Centerpoint Medical Center LLC Suspended
Independence, Missouri, United States, 64057
Mercy Hospital-Joplin Active, not recruiting
Joplin, Missouri, United States, 64804
Research Medical Center Suspended
Kansas City, Missouri, United States, 64132
North Kansas City Hospital Active, not recruiting
Kansas City, Missouri, United States, 64116
Heartland Hematology and Oncology Associates Incorporated Suspended
Kansas City, Missouri, United States, 64118
Saint Luke's Hospital of Kansas City Suspended
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit Suspended
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center Suspended
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint John's Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Heartland Regional Medical Center Suspended
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc Terminated
Saint Joseph, Missouri, United States, 64507
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
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         
Siteman Cancer Center-South County Suspended
Saint Louis, Missouri, United States, 63129
Saint Louis-Cape Girardeau CCOP Withdrawn
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City Active, not recruiting
Saint Louis, Missouri, United States, 63109
Siteman Cancer Center - Saint Peters Suspended
Saint Peters, Missouri, United States, 63376
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Cancer Research for the Ozarks NCORP Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
United States, Nevada
Renown Regional Medical Center Suspended
Reno, Nevada, United States, 89502
United States, New Hampshire
Elliot Hospital Active, not recruiting
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Saint Barnabas Medical Center Suspended
Livingston, New Jersey, United States, 07039
Virtua Memorial Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Lemuel S. Ariaratnam    609-914-6762      
Principal Investigator: Lemuel S. Ariaratnam         
Virtua Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Lemuel S. Ariaratnam    609-914-6762      
Principal Investigator: Lemuel S. Ariaratnam         
United States, New Mexico
University of New Mexico Cancer Center Suspended
Albuquerque, New Mexico, United States, 87102
Memorial Medical Center - Las Cruces Suspended
Las Cruces, New Mexico, United States, 88011
United States, New York
Montefiore Medical Center - Moses Campus Active, not recruiting
Bronx, New York, United States, 10467-2490
The New York Methodist Hospital Suspended
Brooklyn, New York, United States, 11215
Hematology Oncology Associates of Central New York-East Syracuse Withdrawn
East Syracuse, New York, United States, 13057
Mount Sinai Medical Center Withdrawn
New York, New York, United States, 10029
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5830      
Principal Investigator: Yuhchyau Chen         
Highland Hospital Suspended
Rochester, New York, United States, 14620
United States, North Carolina
Park Ridge Hospital Breast Health Center Active, not recruiting
Hendersonville, North Carolina, United States, 28792
Iredell Memorial Hospital Active, not recruiting
Statesville, North Carolina, United States, 28677
Southeast Clinical Oncology Research (SCOR) Consortium NCORP Terminated
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Withdrawn
Akron, Ohio, United States, 44304
Akron General Medical Center Suspended
Akron, Ohio, United States, 44307
Radiation Oncology Center Withdrawn
Alliance, Ohio, United States, 44601
Summa Barberton Hospital Withdrawn
Barberton, Ohio, United States, 44203
UHHS-Chagrin Highlands Medical Center Active, not recruiting
Beachwood, Ohio, United States, 44122
Cleveland Clinic Cancer Center Beachwood Suspended
Beachwood, Ohio, United States, 44122
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 Active, not recruiting
Chardon, Ohio, United States, 44024
Cleveland Clinic Foundation Suspended
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital Suspended
Cleveland, Ohio, United States, 44111
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States, 44106
Ohio State University Comprehensive Cancer 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 Suspended
Independence, Ohio, United States, 44131
Lima Memorial Hospital Terminated
Lima, Ohio, United States, 45804
Cleveland Clinic Cancer Center Mansfield Suspended
Mansfield, Ohio, United States, 44906
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 Suspended
Mayfield Heights, Ohio, United States, 44124
Summa Health Center at Lake Medina Withdrawn
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center Active, not recruiting
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center Active, not recruiting
Middleburg Heights, Ohio, United States, 44130
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 Suspended
Ravenna, Ohio, United States, 44266
Cancer Care Center, Incorporated Terminated
Salem, Ohio, United States, 44460
North Coast Cancer Care Suspended
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville Suspended
Strongsville, Ohio, United States, 44136
Flower Hospital Active, not recruiting
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin Terminated
Tiffin, Ohio, United States, 44883
Saint Vincent Mercy Medical Center Terminated
Toledo, Ohio, United States, 43608
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
Toledo Community Hospital Oncology Program CCOP Terminated
Toledo, Ohio, United States, 43617
Mercy Saint Anne Hospital Terminated
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo Terminated
Toledo, Ohio, United States, 43623
Fulton County Health Center Terminated
Wauseon, Ohio, United States, 43567
UHHS-Westlake Medical Center Active, not recruiting
Westlake, Ohio, United States, 44145
Cancer Treatment Center Terminated
Wooster, Ohio, United States, 44691
Cleveland Clinic Wooster Family Health and Surgery Center Suspended
Wooster, Ohio, United States, 44691
United States, Oklahoma
Warren Clinic Oncology-Tulsa Terminated
Tulsa, Oklahoma, United States, 74146
Warren Cancer Research Foundation Terminated
Tulsa, Oklahoma, United States, 74136
Natalie Warren Bryant Cancer Center at Saint Francis 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: Michael L. Haas    610-988-9323      
Principal Investigator: Michael L. Haas         
United States, South Carolina
AnMed Health Cancer Center Active, not recruiting
Anderson, South Carolina, United States, 29621
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Gibbs Cancer Center-Gaffney Suspended
Gaffney, South Carolina, United States, 29341
Gibbs Cancer Center-Pelham Suspended
Greer, South Carolina, United States, 29651
Spartanburg Medical Center Suspended
Spartanburg, South Carolina, United States, 29303
United States, Texas
Covenant Medical Center-Lakeside Suspended
Lubbock, Texas, United States, 79410
University of Texas Health Science Center at San Antonio Withdrawn
San Antonio, Texas, United States, 78229
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment Suspended
Berlin, Vermont, United States, 05602
University of Vermont Medical Center Suspended
Burlington, Vermont, United States, 05401
University of Vermont College of Medicine Suspended
Burlington, Vermont, United States, 05405
United States, Virginia
Fredericksburg Oncology Inc Terminated
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University/Massey Cancer Center Active, not recruiting
Richmond, Virginia, United States, 23298
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Jondavid Pollock    304-243-6442      
Principal Investigator: Jondavid Pollock         
United States, Wisconsin
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
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: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Bay Area Medical Center Suspended
Marinette, Wisconsin, United States, 54143
Columbia Saint Mary's Hospital - Ozaukee Active, not recruiting
Mequon, Wisconsin, United States, 53097
Columbia Saint Mary's Water Tower Medical Commons Active, not recruiting
Milwaukee, Wisconsin, United States, 53211
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         
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: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Door County Cancer Center Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Eva N. Christensen    800-432-6049      
Principal Investigator: Eva N. Christensen         
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 Suspended
Montreal, Quebec, Canada, H3T 1E2
Korea, Republic of
Keimyung University-Dongsan Medical Center Recruiting
Jung-Ku, Daegu, Korea, Republic of, 700-712
Contact: Jin-Hee Kim    82-53-250-7665    ho@dsmc.or.kr   
Principal Investigator: Jin-Hee Kim         
National Cancer Center-Korea Suspended
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Chonnam National University Hwasun Hospital Active, not recruiting
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    -4882      
Principal Investigator: In A. Kim         
Yonsei University Health System-Severance Hospital Suspended
Seoul, Korea, Republic of, 120-752
Gangnam Severance Hospital Suspended
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: In Kim NRG Oncology
  More Information

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  U10CA180868  U10CA021661 
Study First Received: June 15, 2012
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016