Breast Cancer Clinical Trial

Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

Summary

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

Signed informed consent
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: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

Prior regimens did not include Herceptin.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Study ID:

NCT00051103

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 30 Locations for this study

See Locations Near You

GSK Investigational Site
Chula Vista California, 91911, United States
GSK Investigational Site
Los Angeles California, 90095, United States
GSK Investigational Site
Poway California, 92064, United States
GSK Investigational Site
Fort Myers Florida, 33901, United States
GSK Investigational Site
Plantation Florida, 33324, United States
GSK Investigational Site
Savannah Georgia, 31405, United States
GSK Investigational Site
Park Ridge Illinois, 60068, United States
GSK Investigational Site
Skokie Illinois, 60076, United States
GSK Investigational Site
Skokie Illinois, 60077, United States
GSK Investigational Site
Bettendorf Iowa, 52722, United States
GSK Investigational Site
Des Moines Iowa, 50309, United States
GSK Investigational Site
Baltimore Maryland, 21201, United States
GSK Investigational Site
Royal Oak Michigan, 48073, United States
GSK Investigational Site
Billings Montana, 59101, United States
GSK Investigational Site
Hooksett New Hampshire, 03106, United States
GSK Investigational Site
Durham North Carolina, 27710, United States
GSK Investigational Site
Greenville North Carolina, 27834, United States
GSK Investigational Site
Hickory North Carolina, 28602, United States
GSK Investigational Site
Fargo North Dakota, 58103, United States
GSK Investigational Site
Oklahoma City Oklahoma, 73112, United States
GSK Investigational Site
Tulsa Oklahoma, 74136, United States
GSK Investigational Site
Pittsburgh Pennsylvania, 15213, United States
GSK Investigational Site
Columbia South Carolina, 29210, United States
GSK Investigational Site
Germantown Tennessee, 38138, United States
GSK Investigational Site
Memphis Tennessee, 38104, United States
GSK Investigational Site
Memphis Tennessee, 38120, United States
GSK Investigational Site
Nashville Tennessee, 37203, United States
GSK Investigational Site
Nashville Tennessee, 37205, United States
GSK Investigational Site
Houston Texas, 77025, United States
GSK Investigational Site
Salem Virginia, 24153, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Study ID:

NCT00051103

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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