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PIK 3 CA   is an oncogene that encodes the p110α component of phosphatidylinositol 3‐kinase ( PI 3K); it is the second most frequently mutated gene following the  TP 53 gene. In the clinical setting,   PIK 3 CA   mutations may have favorable prognostic value for hormone receptor‐positive breast cancer patients and, during the past few years,   PIK 3 CA   mutations of cell‐free  DNA  (cf DNA ) have attracted attention as a potential noninvasive biomarker of cancer. However, there are few reports on the clinical implications of   PIK 3 CA   mutations for  TNBC  patients. We investigated the   PIK 3 CA   major mutation status of cf DNA  as a noninvasive biomarker of cancer using droplet digital polymerase chain reaction (dd PCR ), which has high level sensitivity and specificity for cancer mutation, in early‐stage 49 triple negative breast cancer ( TNBC ) patients. A total of 12 (24.4%) of 49 patients had   PIK 3 CA   mutations of cf DNA . In a median follow up of 54.4 months, the presence of   PIK 3 CA   mutations of cf DNA  had significant impacts on relapse‐free survival ( RFS ;  P =  0.0072) and breast cancer‐specific survival ( BCSS ;  P =  0.016), according to the log‐lank test. In a Cox proportional hazards model, the presence of   PIK 3 CA   mutations of cf DNA  had significant prognostic value in the univariate and multivariate analysis. Additionally, the presence of  PIK3CA  mutations of cfDNA was significantly correlated with positive androgen receptor phosphorylated form depending on PI3K signaling pathway (pAR) which is independent favorable prognostic factors of TNBC. We demonstrated that the presence of   PIK 3 CA   major mutations of cf DNA  could be a discriminatory predictor of  RFS  and  BCSS  in early‐stage  TNBC  patients and it was associated with PI3K pathway‐dependent AR phosphorylation.

Prognostic role of PIK 3 CA mutations of cell‐free DNA in early‐stage triple negative breast cancer