Trial Information
Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (best overall response under treatment)
Outcome Time Frame:
study period
Safety Issue:
No
Principal Investigator
Henri Roche, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Claudius Regaud - Toulouse - France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
TCD6595
NCT ID:
NCT00386685
Start Date:
July 2006
Completion Date:
January 2011
Related Keywords:
- Breast Neoplasms
- Cancer
- Breast
- metastatic breast cancer
- Breast Neoplasms
- Neoplasms