drugset / Trial / NCT04335669
NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC
Phase 3
Active not recruiting
325 enrolled
Lund University Hospital
Danish Breast Cancer Cooperative Group · collabSwedish Breast Cancer Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.
Timeline
- Start
- 2019-12-20
- Primary completion
- 2035-09
- Completion
- 2035-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 900 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 75 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | — |
| Comparator | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |