drugset / Trial / NCT00637325
Trastuzumab Optimization Trial in Breast Cancer
Phase 3
Unknown
500 enrolled
Regione Lombardia
Istituto Clinico Humanitas · collabMario Negri Institute for Pharmacological Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomised phase III, multicentre, Italian study designed to investigate the role of trastuzumab in patients with locally advanced and/or metastatic breast cancer over expressing HER2 who received a first line chemotherapy containing trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line study will be conducted in patients progressing to a first line chemotherapy plus trastuzumab.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-05
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |