drugset / Trial / NCT05800756
Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer
Phase 2
Unknown
30 enrolled
Yantai Yuhuangding Hospital
Jiangsu Hengrui Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
In this single arm, open label, phase 2 trial, operable patients with stage II-III HR+/HER2+ breast cancer will be enrolled and receive two cycles of pyrotinib combined with trastuzumab, dalpiciclib and letrozole. Imaging evaluation was performed two weeks later, and patients who achieved CR or PR were continued with the original regimen for 4 cycles. Subjects who did not achieve PR switched to regimen and received 4 cycles of pyrotinib combined with trastuzumab plus chemotherapy. This study aims to assessed the biological effects and safety of pyrotinib combined with trastuzumab, dalpiciclib and letrozole for HR+/HER2+ breast cancer in the neoadjuvant setting.
Timeline
- Start
- 2022-08-04
- Primary completion
- 2024-05-31
- Completion
- 2025-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalpiciclib | Small molecule | 125 mg | Oral |
| Subject | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |