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Effects of AKT Inhibitors for PIK3CA/AKT1/PTEN-Altered Advanced or Metastatic Breast Cancer: A Meta-Analysis of Randomized Clinical Trials

de Moraes FCA, Sano VKT, Pereira CRM, de Laia EA, Stecca C, Magalhães MCF, Tarantino P

Clinical breast cancer, 2025

1,334 participants

Abstract

PURPOSE: We aimed to answer the following question: How effective is the addition of AKT inhibitors to the treatment of advanced or metastatic breast cancer?

METHODS: We searched PubMed, Embase and Cochrane for randomized controlled trials (RCTs) that investigated AKT inhibitors for advanced or metastatic BC. We computed hazard-ratios (HRs) for binary endpoints.

RESULTS: A total of 5 RCTs were included in the meta-analysis, comprising 1,334 patients with BC. The use of AKT inhibitors demonstrated a significant improvement in OS (HR 0.70; 95% CI, 0.58-0.85; P < .001) and PFS (HR 0.6797; 95% CI, 0.5499-0.8403; P < .001) in the overall population. Within the PIK3CA/AKT1/PTEN-altered subgroup (n = 645), the OS rate also significantly favored AKT inhibitors over the control group (HR 0.62; 95% CI, 0.42-0.92; P = .019), as well as PFS (HR 0.5224; 95% CI, 0.3366-0.8105; P = .004).

CONCLUSIONS: Our findings suggest that the incorporation of AKT inhibitors holds promise for treating patients with advanced or metastatic PIK3CA/AKT1/PTEN-altered BC.

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,334 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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