Last updated: 11/04/2018 06:14:24

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

GSK study ID
EGF 20002
See study documents
Clinicaltrials.gov ID
NCT00051103
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Investigational Cancer Drug
    • Enrollment:
    Not applicable
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbrushites M, Maltzman JD, Forster J, Rubin S, Stein S, Burstein HJ. CCX978-Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab containing regimens. Ann Oncol. 2009;20:1026-1031.
    Medical condition
    Metastatic Breast Cancer
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    October 2002 to June 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • (The patient must meet the following criteria in order to be eligible for this study.)
    • Signed informed consent
    • (The patient cannot meet any of the following criteria in order to be eligible for this study.)
    • Prior regimens did not include Herceptin.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chula Vista, California, United States, 91911
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Skokie, Illinois, United States, 60077
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hooksett, New Hampshire, United States, 03106
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Memphis, Tennessee, United States, 38104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-01-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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