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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
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Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
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Location
GSK Investigational Site
Chula Vista, California, United States, 91911
Status
Study Complete
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Location
GSK Investigational Site
Skokie, Illinois, United States, 60077
Status
Study Complete
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Location
GSK Investigational Site
Hooksett, New Hampshire, United States, 03106
Status
Study Complete
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Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
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Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
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Location
GSK Investigational Site
Columbia, South Carolina, United States, 29210
Status
Study Complete
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Location
GSK Investigational Site
Skokie, Illinois, United States, 60076
Status
Study Complete
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Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
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Location
GSK Investigational Site
Fort Myers, Florida, United States, 33901
Status
Study Complete
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Location
GSK Investigational Site
Tulsa, Oklahoma, United States, 74136
Status
Study Complete
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Location
GSK Investigational Site
Salem, Virginia, United States, 24153
Status
Study Complete
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Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309
Status
Study Complete
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Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
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Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
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Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
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Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Study Complete
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Location
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
Status
Study Complete
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Location
GSK Investigational Site
Houston, Texas, United States, 77025
Status
Study Complete
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Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Study Complete
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Location
GSK Investigational Site
Bettendorf, Iowa, United States, 52722
Status
Study Complete
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Location
GSK Investigational Site
Hickory, North Carolina, United States, 28602
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
Study Complete
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Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
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Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Study Complete
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Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Study Complete
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Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
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Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Terminated/Withdrawn
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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
Completed
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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