drugset / Trial / NCT07393425
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Phase 2
Recruiting
50 enrolled
Shanghai Jiao Tong University School of Medicine
Jiangsu HengRui Medicine Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.
Timeline
- Start
- 2026-02-02
- Primary completion
- 2027-09-30
- Completion
- 2032-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 100 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | — |
| Subject | Pyrotinib | Small molecule | 320 mg | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 4.8 mg/kg | — |