drugset / Trial / NCT07527806
Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
Non-randomizedCrossoverOpen-labelTreatment
Summary
This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer. Based on metabolic response after two cycles, patients receive either intenstified treatment (Arm A) or de-escalation treatment (Arm B), alongside with a concurrent standard-treatment control group (Arm C). The study aims to establish a response-adaptive, imaging-guided treatment paradigm to optimize neoadjuvant therapy in HER2-positive breast cancer.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2029-05-01
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | 1 mg | — |
| Subject | Dalpiciclib | Small molecule | 150 mg | — |
| Subject | Exemestane | Small molecule | 25 mg | — |
| Subject | Letrozole | Other / unclassified | 2.5 mg | — |
| Subject | Palbociclib | Small molecule | 125 mg | — |
| Subject | Ribociclib | Small molecule | 600 mg | — |
| Subject | SHR-A1811 | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Docetaxel | Small molecule | 75 mg/m2 | — |
| Background | Hyaluronidase | Protein / enzyme biologic | 20000 iu | — |
| Background | Nab-paclitaxel | Small molecule | 260 mg/m2 | — |
| Background | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Pertuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |