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 November 2015 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: February 4, 2016
Last verified: November 2015
  Purpose
This randomized phase II trial studies how well whole-brain radiation therapy (WBRT) 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. 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/Neu Positive
Male Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
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 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).

  • 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 I (WBRT)
Patients undergo WBRT QD 5 days a week for 3 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Radiation: Whole-Brain Radiotherapy
Undergo WBRT
Other Names:
  • WBRT
  • whole-brain radiation therapy
Experimental: Arm II (lapatinib ditosylate, WBRT)
Patients receive lapatinib ditosylate PO QD on days 1-42 and undergo WBRT as in Arm I.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Lapatinib Ditosylate
Given PO
Other Name: Tykerb
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) 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] >= 2.0)
  • At least 1 measurable, 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 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    205-934-0309      
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    205-934-0309      
Principal Investigator: Jennifer F. De Los Santos         
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: John R. Russell    877-904-4367    pfrancisco@usouthal.edu   
Principal Investigator: John R. Russell         
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 Auburn Faith Hospital Recruiting
Auburn, California, United States, 95602
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Sutter Cancer Centers Radiation Oncology Services-Auburn Recruiting
Auburn, California, United States, 95603
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
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 Recruiting
Cameron Park, California, United States, 95682
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Mercy San Juan Medical Center Active, not recruiting
Carmichael, California, United States, 95608
Sutter Davis Hospital Recruiting
Davis, California, United States, 95616
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Memorial Medical Center Active, not recruiting
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Gynecologic Oncology Active, not recruiting
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Camino Division 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 Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Sutter Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
Mercy General Hospital Radiation Oncology Center Terminated
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Withdrawn
Sacramento, California, United States, 95815
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
California Pacific Medical Center-Pacific Campus Recruiting
San Francisco, California, United States, 94118
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
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 Atlo Medical Foundation-Sunnyvale Active, not recruiting
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville Recruiting
Vacaville, California, United States, 95687
Contact: Christopher U. Jones    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
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 Recruiting
New Britain, Connecticut, United States, 06050
Contact: Neal B. Goldberg    860-224-5660      
Principal Investigator: Neal B. Goldberg         
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
Christiana Care Health System-Christiana Hospital Active, not recruiting
Newark, Delaware, United States, 19718
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
Helen F Graham Cancer Center Active, not recruiting
Newark, Delaware, United States, 19713
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 Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Judith R. Samuels    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Judith R. Samuels         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Judith R. Samuels    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Judith R. Samuels         
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 Active, not recruiting
Atlanta, Georgia, United States, 30342
Northside Hospital-Forsyth Active, not recruiting
Cumming, Georgia, United States, 30041
Piedmont Fayette Hospital Terminated
Fayetteville, Georgia, United States, 30214
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         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Joshua T. Mckenzie    800-622-6877      
Principal Investigator: Joshua T. Mckenzie         
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
Contact: Thomas E. Lad    312-864-9002    tlad@cookcountyhhs.org   
Principal Investigator: Thomas E. Lad         
Saint Joseph Hospital 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
Michiana Hematology Oncology PC-Mishawaka Terminated
Mishawaka, Indiana, United States, 46545
Saint Joseph Regional Medical Center-Mishawaka Terminated
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth Terminated
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend Terminated
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend Terminated
South Bend, Indiana, United States, 46601
South Bend Clinic Terminated
South Bend, Indiana, United States, 46617
Northern Indiana Cancer Research Consortium CCOP Recruiting
South Bend, Indiana, United States, 46628
Contact: Binh N. Tran    574-237-1328      
Principal Investigator: Binh N. Tran         
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    215-728-4790      
Principal Investigator: Aruna Turaka         
United States, Kansas
Menorah Medical Center Active, not recruiting
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital Active, not recruiting
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 Recruiting
Baltimore, Maryland, United States, 21204
Contact: Geoffrey A. Neuner    443-849-3706      
Principal Investigator: Geoffrey A. Neuner         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Minh T. Truong    617-638-8265      
Principal Investigator: Minh T. Truong         
United States, Michigan
Bixby Medical Center Terminated
Adrian, Michigan, United States, 49221
Hickman Cancer Center Terminated
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Michigan Cancer Research Consortium CCOP Terminated
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
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         
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, 49829
Contact: James L. Leenstra    507-645-2655      
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         
Cancer Research Consortium of West Michigan NCORP Terminated
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Gilbert D. Padula    616-685-5225    connie.szczepanek@grcop.org   
Principal Investigator: Gilbert D. Padula         
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
Toledo Clinic Cancer Centers-Monroe Terminated
Monroe, Michigan, United States, 48162
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Lakeland Community Hospital Recruiting
Niles, Michigan, United States, 49120
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Port Huron Terminated
Port Huron, Michigan, United States, 48060
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: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Kathleen J. Yost    616-954-2116    connie.szczepanek@grcop.org   
Principal Investigator: Kathleen J. Yost         
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 Recruiting
Warren, Michigan, United States, 48093
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
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 Active, not recruiting
Burnsville, Minnesota, United States, 55337
Mercy Hospital Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital Active, not recruiting
Edina, Minnesota, United States, 55435
Unity Hospital Active, not recruiting
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood Active, not recruiting
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast Active, not recruiting
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital Active, not recruiting
Minneapolis, Minnesota, United States, 55407
Health Partners Inc Active, not recruiting
Minneapolis, Minnesota, United States, 55454
Hennepin County Medical Center Active, not recruiting
Minneapolis, Minnesota, United States, 55415
North Memorial Medical Health Center Active, not recruiting
Robbinsdale, Minnesota, United States, 55422
Metro Minnesota Community Oncology Research Consortium Terminated
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park Active, not recruiting
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55101
United Hospital Active, not recruiting
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center Active, not recruiting
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital Active, not recruiting
Willmar, Minnesota, United States, 56201
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 Active, not recruiting
Independence, Missouri, United States, 64057
Mercy Hospital-Joplin Active, not recruiting
Joplin, Missouri, United States, 64804
North Kansas City Hospital Active, not recruiting
Kansas City, Missouri, United States, 64116
Saint Luke's Hospital of Kansas City Active, not recruiting
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated Active, not recruiting
Kansas City, Missouri, United States, 64118
Research Medical Center Active, not recruiting
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit Active, not recruiting
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center Active, not recruiting
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    417-820-3587    jay.carlson@mercy.net   
Principal Investigator: Jay W. Carlson         
Saint John's Clinic-Rolla-Cancer and Hematology Active, not recruiting
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center Active, not recruiting
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc Terminated
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City Active, not recruiting
Saint Louis, Missouri, United States, 63109
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 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         
Mercy Hospital Saint Louis Active, not recruiting
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP Withdrawn
Saint Louis, Missouri, United States, 63141
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         
Cancer Research for the Ozarks NCORP Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Michael C. Hardacre    775-982-4400      
Principal Investigator: Michael C. Hardacre         
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 Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87102
Memorial Medical Center - Las Cruces Active, not recruiting
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
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
Highland Hospital Active, not recruiting
Rochester, New York, United States, 14620
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
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 Active, not recruiting
Akron, Ohio, United States, 44307
Radiation Oncology Center Withdrawn
Alliance, Ohio, United States, 44601
Summa Barberton Hospital Withdrawn
Barberton, Ohio, United States, 44203
Cleveland Clinic Cancer Center Beachwood Recruiting
Beachwood, Ohio, United States, 44122
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
UHHS-Chagrin Highlands Medical Center Active, not recruiting
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 Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel T. Chao    216-445-1068    chaos@ccf.org   
Principal Investigator: Samuel T. Chao         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
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 Recruiting
Independence, Ohio, United States, 44131
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
Lima Memorial Hospital Terminated
Lima, Ohio, United States, 45804
Cleveland Clinic Cancer Center Mansfield Recruiting
Mansfield, Ohio, United States, 44906
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
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: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
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 Terminated
Ravenna, Ohio, United States, 44266
Cancer Care Center, Incorporated Terminated
Salem, Ohio, United States, 44460
North Coast Cancer Care Recruiting
Sandusky, Ohio, United States, 44870
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
Cleveland Clinic Cancer Center Strongsville Recruiting
Strongsville, Ohio, United States, 44136
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
Flower Hospital Active, not recruiting
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
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
Saint Vincent Mercy Medical Center Terminated
Toledo, Ohio, United States, 43608
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 Recruiting
Wooster, Ohio, United States, 44691
Contact: Samuel T. Chao    866-223-8100      
Principal Investigator: Samuel T. Chao         
United States, Oklahoma
Natalie Warren Bryant Cancer Center at Saint Francis Terminated
Tulsa, Oklahoma, United States, 74136
Warren Cancer Research Foundation Terminated
Tulsa, Oklahoma, United States, 74136
Warren Clinic Oncology-Tulsa Terminated
Tulsa, Oklahoma, United States, 74146
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 Recruiting
Gaffney, South Carolina, United States, 29341
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
United States, Texas
Covenant Medical Center-Lakeside Recruiting
Lubbock, Texas, United States, 79410
Contact: Paul J. Anderson    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Paul J. Anderson         
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 Recruiting
Berlin, Vermont, United States, 05602
Contact: Deborah Z. Rubin    802-656-4101      
Principal Investigator: Deborah Z. Rubin         
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Deborah Z. Rubin    802-656-4101      
Principal Investigator: Deborah Z. Rubin         
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Deborah Z. Rubin    802-656-4101      
Principal Investigator: Deborah Z. Rubin         
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: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: James L. Leenstra    507-645-2655      
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    507-645-2655      
Principal Investigator: James L. Leenstra         
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
UW Cancer Center Johnson Creek Active, not recruiting
Johnson Creek, Wisconsin, United States, 53038
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
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 Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
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    507-645-2655      
Principal Investigator: James L. Leenstra         
Door County Cancer Center Recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Contact: James L. Leenstra    507-645-2655      
Principal Investigator: James L. Leenstra         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: James L. Leenstra    507-645-2655      
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 Active, not recruiting
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       ho@dsmc.or.kr   
Principal Investigator: Jin-Hee Kim         
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 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    888-823-5923    ctsucontact@westat.com   
Principal Investigator: In A. Kim         
Yonsei University Health System-Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Chang Ok Suh    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Chang Ok Suh         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Ik Jae Lee    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Ik Jae Lee         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: In Ah Kim NRG Oncology
  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  U10CA180868  U10CA021661 
Study First Received: June 15, 2012
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Carcinoma
Neoplasms
Neoplasms, Second Primary
Breast Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Lapatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016