drugset / Trial / NCT00485979

Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

NCT00485979 ↗

Phase 2 Completed 330 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria). The secondary objectives are: * to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria, * to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.

Timeline

Start
2007-06
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule — Intravenous
Subject Trastuzumab Monoclonal antibody — Intravenous
Subject larotaxel Small molecule 90 mg/m2 Intravenous

Indications