Clinical Trial: NCT04851613
Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Laekna Limited |
| Information Provided By: | Laekna Limited |
| Last Update Posted: | 2026-04-02 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Afuresertib
- Drug: Afuresertib/placebo
Other Study ID Numbers
- LAE205INT3101
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Laekna Limited |
| Information Provided By: | Laekna Limited |
| Last Update Posted: | 2026-04-02 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Afuresertib
- Drug: Afuresertib/placebo
Other Study ID Numbers
- LAE205INT3101