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.
Protocol Amendment History
13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2021-04-19; most recent amendment 2026-03-31.
Status change: Recruiting → Active, Not Recruiting2026-03-31
Status change: Active, Not Recruiting → Recruiting2024-06-13
Status change: Recruiting → Active, Not Recruiting2023-06-05
Status change: Not Yet Recruiting → Recruiting2022-04-14