XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00386685
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2008-10
• Study Completion: 2011-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• Metastatic breast cancer (MBC)
• HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
• Adequate organs functions

Exclusion Criteria

• More than one previous chemotherapy regimen for metastatic disease
• Cardiac dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate (best overall response under treatment)	study period

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3-4 toxicities, pharmacokinetic interaction	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇭 Geneva, Switzerland