drugset / Trial / NCT01597414
Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1
Phase 2
Completed
80 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients. The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.
Timeline
- Start
- 2013-06
- Primary completion
- 2017-03
- Completion
- 2022-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |