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Brain Metastases in ErbB2-Positive Breast Cancer
This study is currently recruiting patients.
Verified by GlaxoSmithKline December 2005
Sponsored by:GlaxoSmithKlineInformation provided by:GlaxoSmithKlineClinicalTrials.gov Identifier:NCT00263588
Purpose
The purpose of this study is to determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.
Condition InterventionPhaseMetastatic Breast Cancer
Drug: lapatinib
Phase II
MedlinePlus related topics:
Breast Cancer;
Cancer
Genetics Home Reference related topics:
breast cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-Based Systemic Therapy and Cranial Radiotherapy
Further Study Details:
Primary Outcomes: To determine the response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.
Secondary Outcomes: No secondary outcomes
Expected Total Enrollment: 220
Study start: November 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- <LI style="MARGIN-TOP: 2px">Signed Informed Consent
- ErbB2(HER2)overexpressing breast cancer.
- Brain lesion(s) which are progressing.
- Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
- Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
- Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
- Able to swallow an oral medication.
- Adequate kidney and liver function.
- Adequate bone marrow function.
Exclusion criteria:
- <LI style="MARGIN-TOP: 2px">Pregnant or lactating females.
- Conditions that would effect the absorption of an oral drug.
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
- Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
- Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00263588
GSK Clinical Trials Call Center: Refer to Study "EGF105084" 1-877-379-3718
Alabama
GSK Clinical Trials Call Center, Birmingham, Alabama, 35205, United States; Recruiting James Cantrell 877-379-3718
lisa.moore@usoncology.com
Arizona
GSK Clinical Trials Call Center, Sedona, Arizona, 86336, United States; Recruiting Deborah Lindquist 877-379-3718
GSK Clinical Trials Call Center, Tuscon, Arizona, 85724-5024, United States; Not yet recruiting Allison Stopeck 877-379-3718
California
GSK Clinical Trials Call Center, Vallejo, California, 94589, United States; Not yet recruiting Louis Fehrenbacher 877-379-3718
desiree.goldstein@kp.org
GSK Clinical Trials Call Center, Long Beach, California, 90813-3244, United States; Not yet recruiting Andre Liem 877-379-3718
andrel@pacshoresoncology.com
GSK Clinical Trials Call Center, Northridge, California, 91328, United States; Not yet recruiting Sheldon Davidson 877-379-3718
sheljdavid@aol.com
GSK Clinical Trials Call Center, Redondo Beach, California, 90277, United States; Not yet recruiting David Chan 877-379-3718
Cca.rb@verizon.net
GSK Clinical Trials Call Center, San Francisco, California, 94115, United States; Not yet recruiting Michelle Melisko 877-379-3718
Lauren.Metzroth@ucsfmedctr.org
GSK Clinical Trials Call Center, Los Angeles, California, 90095-1678, United States; Not yet recruiting Mark Pegram 877-379-3718
pocandela@mednet.ucla.edu
GSK Clinical Trials Call Center, Bakersfield, California, 93309, United States; Not yet recruiting Ravi Patel 877-379-3718
lgood@cbccusa.com
GSK Clinical Trials Call Center, Pomona, California, 91767, United States; Not yet recruiting Linda Bosserman 877-379-3718
linda.bosserman@womgi.com
GSK Clinical Trials Call Center, Santa Barbara, California, 93105, United States; Not yet recruiting Frederic Kass 877-379-3718
Fkass@ccsb.org
GSK Clinical Trials Call Center, Fullerton, California, 92835, United States; Not yet recruiting Richard E. Lloyd 877-379-3718
rlloyd@sjf.stjoe.org
GSK Clinical Trials Call Center, Alhambra, California, 91801, United States; Not yet recruiting Eddie Hu 877-379-3718
eddiehu@pacbell.net
Colorado
GSK Clinical Trials Call Center, Denver, Colorado, 80220, United States; Recruiting Devchand Paul 877-379-3718
District of Columbia
GSK Clinical Trials Call Center, Washington, District of Columbia, 20007, United States; Recruiting Minetta Liu 877-379-3718
liumc@georgetown.edu
Florida
GSK Clinical Trials Call Center, Jacksonville, Florida, 32224-1865, United States; Not yet recruiting Edith Perez 877-379-3718
bailey.elizabeth@mayo.edu
GSK Clinical Trials Call Center, Plantation, Florida, 33324, United States; Not yet recruiting Charles Vogel 877-379-3718
drcvogel@aol.com
Georgia
GSK Clinical Trials Call Center, Athens, Georgia, 30607, United States; Not yet recruiting R. Glen Wiggans 877-379-3718
Illinois
GSK Clinical Trials Call Center, Chicago, Illinois, 60611, United States; Not yet recruiting William Gradishar 877-379-3718
a-sheerer2@northwestern.edu
Indiana
GSK Clinical Trials Call Center, Indianapolis, Indiana, 46202, United States; Not yet recruiting Anna Maria Storniolo 877-379-3718
astornio@iupui.edu
GSK Clinical Trials Call Center, Indianapolis, Indiana, 46227, United States; Recruiting David Loesch 877-379-3718
sara.campbell@usoncology.com
Iowa
GSK Clinical Trials Call Center, Sioux City, Iowa, 51101, United States; Not yet recruiting Stephen Kahanic 877-379-3718
shoaresearch@shoa-research.com
Kansas
GSK Clinical Trials Call Center, Kansas City, Kansas, 66160, United States; Not yet recruiting Carol Fabian 877-379-3718
rclark-snow@kumc.edu
Maryland
GSK Clinical Trials Call Center, Baltimore, Maryland, 21231, United States; Not yet recruiting Antonio Wolff 877-379-3718
sjeter1@jhmi.edu
Massachusetts
GSK Clinical Trials Call Center, Boston, Massachusetts, 02115, United States; Not yet recruiting Nancy Lin 877-379-3718
khurtley@bidmc.harvard.edu
Michigan
GSK Clinical Trials Call Center, Ann Arbor, Michigan, 48109-0942, United States; Not yet recruiting Daniel F. Hayes 877-379-3718
jhayden@umich.edu
Minnesota
GSK Clinical Trials Call Center, Minneapolis, Minnesota, 55455, United States; Not yet recruiting Douglas Yee 877-379-3718
gayxx001@umn.edu
GSK Clinical Trials Call Center, Minneapolis, Minnesota, 55404, United States; Recruiting Patrick Flynn 877-379-3718
Missouri
GSK Clinical Trials Call Center, St. Louis, Missouri, 63110, United States; Not yet recruiting Michael Naughton 877-379-3718
mellis@im.wustl.edu
Nevada
GSK Clinical Trials Call Center, Las Vegas, Nevada, 89109, United States; Not yet recruiting Heather Allen 877-379-3718
Heather.Allen@unoncology.com
GSK Clinical Trials Call Center, Henderson, Nevada, 89052, United States; Not yet recruiting Paul E. Michael 877-379-3718
pmichael@usoncolgy.com
New Mexico
GSK Clinical Trials Call Center, Albuquerque, New Mexico, 87131, United States; Not yet recruiting Melanie Royce 877-379-3718
tstewart@nmcca.org
New York
GSK Clinical Trials Call Center, New York, New York, 10021-6007, United States; Not yet recruiting Monica Fornier 877-379-3718
North Carolina
GSK Clinical Trials Call Center, Chapel Hill, North Carolina, 27599, United States; Not yet recruiting Lisa Carey 877-379-3718
lisa_carey@med.unc.edu
Pennsylvania
GSK Clinical Trials Call Center, Philadelphia, Pennsylvania, 19104-4283, United States; Not yet recruiting Angela DeMichele 877-379-3718
angela.klem@uphs.upenn.edu
GSK Clinical Trials Call Center, Pittsburg, Pennsylvania, 15213, United States; Not yet recruiting Adam Brufsky 877-379-3718
clearydl@upmc.edu
Tennessee
GSK Clinical Trials Call Center, Nashville, Tennessee, 37203, United States; Not yet recruiting Denise Yardley 877-379-3718
hburris@tnonc.com
Texas
GSK Clinical Trials Call Center, Dallas, Texas, 75246, United States; Recruiting Joanne Blum 877-379-3718
GSK Clinical Trials Call Center, Houston, Texas, 77030, United States; Not yet recruiting Jenny Chang 877-379-3718
taraj@breastcenter.tmc.edu
GSK Clinical Trials Call Center, San Antonio, Texas, 78258, United States; Not yet recruiting Gladys Rodriguez 877-379-3718
GSK Clinical Trials Call Center, Tyler, Texas, 75702, United States; Recruiting Donald Richards 877-379-3718
Washington
GSK Clinical Trials Call Center, Seattle, Washington, 98109-1023, United States; Not yet recruiting Hannah Linden 877-379-3718
mitraz@u.washington.edu
GSK Clinical Trials Call Center, Yakima, Washington, 98902, United States; Recruiting Vicky Jones 877-379-3718
Beth.Parker@usoncology.com
Belgium
GSK Clinical Trials Call Center, Brussels, 01000, Belgium; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
France
GSK Clinical Trials Call Center, Toulouse, 31052, France; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center, Paris, 75248, France; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center, Dijon, 21079, France; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center, Paris, 75475, France; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
Greece
GSK Clinical Trials Call Center, Athens, 115 26, Greece; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
Italy
GSK Clinical Trials Call Center, Perugia, 06132, Italy; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center, Milano, 20141, Italy; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
Sweden
GSK Clinical Trials Call Center, Uppsala, 751 85, Sweden; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
United Kingdom
GSK Clinical Trials Call Center, Manchester, M20 4BX, United Kingdom; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718
Study chairs or principal investigators
GSK Clincial Trials, MD, Study Director, GlaxoSmithKline
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