Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer

Summary

Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CDK4/6 inhibitor (up to 1 therapy), and/or chemotherapy (up to 1 chemotherapy) as described in the inclusion criteria.

Timeline

Start

2022-02-18

Primary completion

2026-10-30

Completion

2026-12-30

Publications

• Zhang P, Sun T, Wang Y, Li W, Tong Z, Phadke S, Feinstein T, Ma W, Guo P, Zhang M, Yue Y, Xu B. Afuresertib plus fulvestrant for pretreated HR-positive, HER2-negative, advanced breast cancer: a phase Ib trial. Nat Commun. 2026 Feb 6;17(1):2456. doi: 10.1038/s41467-026-69225-2.

Drugs

Indications