XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Trastuzumab

Criteria

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