NCT00810017|TerminatedPhase 2ResultsDMC
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Terminated due to difficulty in accruing patients
Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.
Sponsor study identifier
interventional
2
1 country
1
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
June 2010
Actual (reported)This study is for women and men who have previously treated metastatic (has spread to other parts in the body), Her2- positive breast cancer. The purpose of this study is to find out what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this type of breast cancer and to determine if these drugs are safe to use together. This research is being done to find more effective treatment for this type of condition. In this study, trastuzumab and etoposide will be given by intravenous infusion (IV; through a vein) on the first 3 days of every 3-week cycle. This is repeated for 6 cycles. After 6 cycles, only trastuzumab will be given until worsening of disease. In this study, a small amount of your tissue that was collected when you had surgery will be evaluated in the lab to look at genetic differences among people and how those differences may affect a response to a specific drug or medicine. This testing will look for a gene called Top2A. Previous studies suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies (anti-cancer drugs) differently from those who only have the Her2 gene.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2008
Actual (reported)December 17, 2008
Actual (reported)February 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)June 2010
Actual (reported)May 19, 2022
Actual (reported)To Determine ORR of Trastuzumab Combined With Etoposide in Patients With HER2 Positive Metastatic Breast Cancer, and to Assess Toxicity of the Combination of Trastuzumab With Intravenous Etoposide.
To determine the overall response rate
The best overall response is the best response recorded from the start of first treatment until the date of first progression or date of death from any cause whichever came first, assessed up to 24 months
To Determine Efficacy of Trastuzumab Combined With Etoposide in Patients With HER2-positive Metastatic Breast Cancer, and to Assess Toxicity of the Combination of Trastuzumab With Intravenous Etoposide.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
From the start of first treatment until unacceptable toxicity or date of death, whichever came first, over 24 months
Determine Duration of Response
Stable disease is measured from the start of the treatment until the criteria for progression are met, assessed by CT scans at a minimum interval of 8 weeks over 5 years
Determine Duration of Response
Time to disease progression is defined as time from registration date to the date of documented disease progression or death on study, whichever occurs first for 5 years
Determine Duration of Response
The progression-free survival rate is defined as the percentage of patients who are without disease progression while on the study treatment at the end of study, over 5 years
Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression
etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Sandra M Swain, MD
Medstar Health Research Institute
2 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
May 19, 2022
Results First Posted
May 19, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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