drugset / Trial / NCT04293276

Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

NCT04293276 ↗

NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

Timeline

Start
2020-04-01
Primary completion
2021-08-23
Completion
2023-05

Outcome

Met primary endpoint

paper With a median follow-up of 25.9 months, 70% (28/40) of assessable patients have a confirmed objective response, meeting the primary endpoint. PMID 37805496 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule — Oral
Subject Pyrotinib Small molecule — Oral

Indications