Viewing Study NCT00433095



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Study NCT ID: NCT00433095
Status: COMPLETED
Last Update Posted: 2011-03-14
First Post: 2007-02-07

Brief Title: Vinorelbine Oral Plus Trastuzumab for 1st-line Treatment of HER2Neu Overexpressing Breast Cancer
Sponsor: Ludwig-Maximilians - University of Munich
Organization: Ludwig-Maximilians - University of Munich

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2007-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 1st-line treatment of HER2neu overexpressing breast cancer
Detailed Description: The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78 This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None