Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
NCT ID: NCT00051103
Last Updated: 2015-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2002-10-31
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Investigational Cancer Drug
Eligibility Criteria
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Inclusion Criteria
* No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
* Refractory Stage IIIb or IV breast cancer
* HER2/neu tumor overexpression
* Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
* Tumor tissue available for testing.
* 2 weeks since treatment with Herceptin (alone or in combination).
* Able to swallow and retain oral medication
* Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
* Adequate kidney and liver function
* Adequate bone marrow function
Exclusion Criteria
* Pregnant or lactating.
* Conditions that would affect absorption of an oral drug
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
* Severe cardiovascular disease or cardiac disease requiring a device.
* Active infection.
* Brain metastases.
* Concurrent cancer therapy or investigational therapy.
* Use of oral or IV steroids.
* Unresolved or unstable serious toxicity from prior therapy.
* Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Chula Vista, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Poway, California, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Park Ridge, Illinois, United States
GSK Investigational Site
Skokie, Illinois, United States
GSK Investigational Site
Skokie, Illinois, United States
GSK Investigational Site
Bettendorf, Iowa, United States
GSK Investigational Site
Des Moines, Iowa, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Royal Oak, Michigan, United States
GSK Investigational Site
Billings, Montana, United States
GSK Investigational Site
Hooksett, New Hampshire, United States
GSK Investigational Site
Durham, North Carolina, United States
GSK Investigational Site
Greenville, North Carolina, United States
GSK Investigational Site
Hickory, North Carolina, United States
GSK Investigational Site
Fargo, North Dakota, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Columbia, South Carolina, United States
GSK Investigational Site
Germantown, Tennessee, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Salem, Virginia, United States
Countries
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References
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Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29.
Related Links
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A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.
Other Identifiers
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EGF 20002
Identifier Type: -
Identifier Source: org_study_id
NCT00044330
Identifier Type: -
Identifier Source: nct_alias
NCT00053066
Identifier Type: -
Identifier Source: nct_alias
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