SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

Summary

This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.

Timeline

Start

2018-07-25

Primary completion

2019-10-14

Completion

2019-10-14

Outcome

Outcome not reported

Stopped (Business): “Sponsor R \& D Strategy Adjustment”

Drugs

Indications