XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer

Sanofi

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: larotaxel (XRP9881); Drug: trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386685

TCD6595

XRP9881

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)