drugset / Trial / NCT07179939
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
Phase 2
Not yet recruiting
288 enrolled
Fudan University
Chinese PLA General Hospital · collabJiangsu HengRui Medicine Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses following trastuzumab rezetecan (T-DXh, SHR-A1811) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.
Timeline
- Start
- 2025-09-10
- Primary completion
- 2030-12-30
- Completion
- 2031-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | — | — |
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Subject | Exemestane | Small molecule | — | — |
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | Goserelin | Other / unclassified | — | — |
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Leuprolide | Other / unclassified | — | — |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | — | — |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |