drugset / Trial / NCT01996267
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
Phase 3
Active not recruiting
437 enrolled
The Netherlands Cancer Institute
Borstkanker Onderzoek Groep · collabRoche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study compares two schedules of upfront chemotherapy in HER positive breast cancer.
Timeline
- Start
- 2013-12
- Primary completion
- 2018-12
- Completion
- 2030-12
Publications
- van der Voort A, van Ramshorst MS, van Werkhoven ED, Mandjes IA, Kemper I, Vulink AJ, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS. Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 Randomized, Phase 3 Trial. JAMA Oncol. 2021 Jul 1;7(7):978-984. doi: 10.1001/jamaoncol.2021.1371.
- van Ramshorst MS, van der Voort A, van Werkhoven ED, Mandjes IA, Kemper I, Dezentje VO, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS; Dutch Breast Cancer Research Group (BOOG). Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1630-1640. doi: 10.1016/S1470-2045(18)30570-9. Epub 2018 Nov 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 3 unknown | — |
| Comparator | Carboplatin | Small molecule | 6 unknown | — |
| Comparator | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 500 mg/m2 | — |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |