Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
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
1 other identifier
interventional
N/A
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2002
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 3, 2003
CompletedFirst Posted
Study publicly available on registry
January 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedApril 15, 2015
April 1, 2015
2.7 years
January 3, 2003
April 14, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
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
Related Publications (1)
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.
PMID: 19179558BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2003
First Posted
January 6, 2003
Study Start
October 1, 2002
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
April 15, 2015
Record last verified: 2015-04