HS-10342-201 is a single- arm, open- label, multicenter, phase 2 study in patients with hormone receptor positive (HR positive), human epidermal growth factor receptor 2 negative (HER2 negative) advanced and/or metastatic breast cancer who have had disease progression after endocrine therapy. The efficacy is evaluated as monotherapy, and the primary endpoint is ORR.
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.