OncoMatch/Clinical Trials/NCT04851613
Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer
Is NCT04851613 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Afuresertib for breast cancer.
Treatment: Afuresertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA any tested
Only patients with PIK3CA/AKT1/PTEN alterations could include.
Required: AKT1 any tested
Only patients with PIK3CA/AKT1/PTEN alterations could include.
Required: PTEN any tested
Only patients with PIK3CA/AKT1/PTEN alterations could include.
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — locally advanced or metastatic
Have received 1 to 2 prior lines of systemic treatments for LABC or mBC (at least one line was ET). If disease relapse during adjuvant therapy or relapse within 12 months from completion of adjuvant endocrine therapy, the adjuvant therapy will be counted as 1 line
Cannot have received: fulvestrant
Patients who had prior treatment with fulvestrant
Cannot have received: selective estrogen receptor degrader
Patients who had prior treatment with ... other selective estrogen receptor degraders (SERDs)
Cannot have received: PI3K inhibitor
Patients who had prior treatment with ... any PI3K/AKT/mTOR inhibitors
Cannot have received: AKT inhibitor
Patients who had prior treatment with ... any PI3K/AKT/mTOR inhibitors
Cannot have received: mTOR inhibitor
Patients who had prior treatment with ... any PI3K/AKT/mTOR inhibitors
Cannot have received: CDK4/6 inhibitor
Patients who had prior treatment with ... any CDK4/6 inhibitors in phase I, II study
Lab requirements
Blood counts
Kidney function
Liver function
Patients who have adequate organ function as defined.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Providence St. Johns Health Center · Santa Monica, California
- Piedmont Cancer Institute · Atlanta, Georgia
- University of Iowa · Iowa City, Iowa
- University of Mississippi Medical Center · Jackson, Mississippi
- University of Vermont · Burlington, Vermont
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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