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

Last updated: April 14, 2015
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

2

Condition

Metastatic Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT00051103
EGF 20002
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

  • Signed informed consent

  • No more than two prior regimens for metastatic breast cancer. Each regimen must havecontained Herceptin.

  • Refractory Stage IIIb or IV breast cancer

  • HER2/neu tumor overexpression

  • Disease progression while receiving a prior chemotherapy regimen with Herceptin aloneor 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

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to beeligible 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 safetyor 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 thanHerceptin.

Study Design

Study Start date:
October 01, 2002
Estimated Completion Date:
June 30, 2005

Connect with a study center

  • GSK Investigational Site

    Chula Vista, California 91911
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • GSK Investigational Site

    Poway, California 92064
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • GSK Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 31405
    United States

    Site Not Available

  • GSK Investigational Site

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • GSK Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • GSK Investigational Site

    Bettendorf, Iowa 52722
    United States

    Site Not Available

  • GSK Investigational Site

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • GSK Investigational Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • GSK Investigational Site

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • GSK Investigational Site

    Billings, Montana 59101
    United States

    Site Not Available

  • GSK Investigational Site

    Hooksett, New Hampshire 03106
    United States

    Site Not Available

  • GSK Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • GSK Investigational Site

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • GSK Investigational Site

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29210
    United States

    Site Not Available

  • GSK Investigational Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77025
    United States

    Site Not Available

  • GSK Investigational Site

    Salem, Virginia 24153
    United States

    Site Not Available

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