drugset
drugset / Trial / NCT05328440

Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

NCT05328440 ↗

Phase 2 Unknown 120 enrolled Henan Cancer Hospital Jiangsu HengRui Medicine Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.

Timeline

Start
2022-05-20
Primary completion
2024-06-01
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 400 mg Oral
Subject Fulvestrant Small molecule 500 mg Intravenous
Subject Inetetamab Monoclonal antibody 6 mg/kg Intravenous
Subject Pyrotinib Small molecule 125 mg —

Indications

breast cancer