drugset / Trial / NCT03820063
Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
Phase 2
Active not recruiting
462 enrolled
Dutch Breast Cancer Research Group
BOOG Study Center · collabRoche Pharma AG · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.
Timeline
- Start
- 2019-02-27
- Primary completion
- 2022-11-15
- Completion
- 2032-05-01
Publications
- Louis FM, van der Voort A, van Ramshorst MS, Daletzakis A, Mandjes IA, Kemper I, Agterof MJ, van der Steeg WA, Heijns JB, van Bekkum ML, Siemerink EJM, Kuijer PM, Scholten A, Wesseling J, Vrancken Peeters MTFD, Egeler MD, van de Poll-Franse LV, Mann RM, Sonke GS; Dutch Breast Cancer Research Group (BOOG). MRI-based personalisation of neoadjuvant chemotherapy duration in HER2-positive early breast cancer (TRAIN-3): primary results from a multicentre, single-arm, phase 2 study. Lancet Oncol. 2026 Mar;27(3):349-360. doi: 10.1016/S1470-2045(25)00707-7. Epub 2026 Feb 16.
- van der Voort A, Louis FM, van Ramshorst MS, Kessels R, Mandjes IA, Kemper I, Agterof MJ, van der Steeg WA, Heijns JB, van Bekkum ML, Siemerink EJ, Kuijer PM, Scholten A, Wesseling J, Vrancken Peeters MTFD, Mann RM, Sonke GS; Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II-III HER2-positive breast cancer (TRAIN-3): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 May;25(5):603-613. doi: 10.1016/S1470-2045(24)00104-9. Epub 2024 Apr 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 6 mg/ml | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |