drugset / Trial / NCT01548677
Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
Phase 2
Completed
1317 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Hoffmann-La Roche · collabJanssen Diagnostics, LLC · collabSUCCESS · collabUNICANCER · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.
Timeline
- Start
- 2013-04
- Primary completion
- 2017-03
- Completion
- 2017-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |