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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.

Phase 3RecruitingLaekna LimitedNCT04851613Data as of May 2026

Treatment: AfuresertibStudy 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.

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Extracted 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

Max 2 prior lines
Min 1 prior line

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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