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A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer. (SATIN)
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 330 |
| Start date | 2007-06 |
| Completion | 2010-08 |
Conditions
- Breast Neoplasms
Interventions
- larotaxel (XRP9881)
- docetaxel
- trastuzumab
Primary outcomes
- Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. — treatment period
Countries
Belgium, Brazil, France, Germany, Poland, Tunisia, United Kingdom, Uruguay