NCT00810017

Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer

Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HER-2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Etoposide	etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles
DRUG	Trastuzumab	intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2008-12-17
• Last updated: 2022-05-19
• Results posted: 2022-05-19

Locations

1 site across 1 country: United States