drugset / Trial / NCT03705429
A Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
Phase 3
Completed
51 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
The Ottawa Hospital · collab
RandomizedParallel-groupSingle-blindOther
Summary
Multi-center, open-label, randomized trial of patients with low-risk, HER2+ disease, who will receive adjuvant taxane-based chemotherapy (i.e. docetaxel and cyclophosphamide with trastuzumab \[TC-H\] or weekly paclitaxel with trastuzumab \[P-H\]) at the standard approved doses, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.
Timeline
- Start
- 2019-05-01
- Primary completion
- 2022-05-11
- Completion
- 2022-05-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | — |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |