Gene

PIK3CA

phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

Explore in graph →CI-GENE-00019747HGNC:8975 ENSG00000121879 NCBI 5290 CIViC Cancer geneApproved

Curated evidence

Clinical evidence (298)

CIViC items involving this gene, grouped by molecular profile and therapy, with native levels and directions. 50 items per page.

civicCuratedShowing 101–150 of 298 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA E545A + PIK3CA E545D + PIK3CA E545G + PIK3CA E545K + PIK3CA E545L + PIK3CA E545Q + PIK3CA E545R + PIK3CA E545V1
Fulvestrant + Inavolisib + PalbociclibCombination	Malignant Breast Neoplasm	Predictive

Cohorts

Alteration frequency by cohort (200)

Frequency = cases affected / cases profiled within one cohort. Cohorts are never pooled.

cbioportalObserved200 cohort rows (showing 50, sorted by frequency) · frequency = affected / profiled, as published by each cohort; cohorts are not pooled. Hover a row badge for its release.

Cohort	Mapped cancer	Alteration	Affected (n)	Profiled (n)	Frequency (%)	Rank in cohort	Source
Head and Neck Squamous Cell Carcinoma (TCGA, Firehose Legacy) hnsc_tcga	Head and Neck Squamous Cell Carcinoma	Ssm	94	512

Literature

Linked publications (65)

25 per page, newest first.

pubmedPublishedShowing 1–25 of 65 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer.
· N Engl J Med · 2019 · PMID 31091374 · validated civic_curation pubmed
Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer.
· N Engl J Med · 2023 · PMID 37256976 · validated civic_curation pubmed
US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.
· J Clin Oncol · 2025 · PMID 40845250 · validated civic_curation pubmed
PIK3CA mutation is associated with poor survival among patients with metastatic colorectal cancer following anti-EGFR monoclonal antibody therapy: a meta-analysis.

PIK3CA E545Q3
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12187 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Does Not Support Resistance	3	accepted	EID2213 Two patients participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored PIK3CA E545Q (exon 10), were wildtype for NRAS, B… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
PI103	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID2046 In H460, a gefitinib-resistant NSCLC cell line that harbors PIK3CA mutations, the dual PI3Kalpha/mTOR inhibitor PI103 reduced cell growth and increased the expression of the tumor suppressor p53 compa… (full text at CIViC) PMID 19513541 · Zou et al., 2009 · Open in CIViC	civic

PIK3CA E545Q3

Capivasertib + FulvestrantCombination

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID12187

In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC)

PMID 37256976 · Turner et al., 2023 · Open in CIViC

PIK3CA E545V4
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	submitted	EID3725 In metastatic colorectal cancer, the objective tumor response rate to the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies cetuximab or panitumumab was lower in patients with PIK3CA … (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	rejected	EID3726 In colorectal cancer patients treated with salvage cetuximab therapy in combination with chemotherapy, PIK3CA mutations were associated with reduced progression-free survival (2.5mo vs. 3.9mo, HR:2.1,… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	submitted	EID2073 In metastatic colorectal cancer, the objective tumor response rate to the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies cetuximab or panitumumab was lower in patients with PIK3CA … (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
Trastuzumab	Malignant Breast Neoplasm	Predictive	C	Supports Resistance	—	submitted	EID2072 In HER2-positive metastic breast cancer patients treated with trastuzumab-based therapy, the presence of a PIK3CA mutation was associated with an increased risk of progression (HR:2.50, 95% CI:1.35-4.… (full text at CIViC) PMID 21594665 · Razis et al., 2011 · Open in CIViC	civic

PIK3CA E81K2
(diagnostic)	PIK3CA-Related Overgrowth SpectrumUNRESOLVED	Diagnostic	C	Supports Positive	3	submitted	EID9483 In a study examining PIK3CA variants associated with PIK3CA-Related Overgrowth Syndrome (PROS), somatic PIK3CA E81K (c.241 G>A) was identified at various allele frequencies in hair follicles, saliva, … (full text at CIViC) PMID 25915946 · Loconte et al., 2015 · Open in CIViC	civic
Cetuximab + Fluorouracil + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Does Not Support Resistance	2	accepted	EID4464 Two patients participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored PIK3CA E81K, were wildtype for NRAS, BRAF and PIK… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

PIK3CA Exon 10 Mutation3
(prognostic)	Malignant Breast Neoplasm	Prognostic	B	Supports Poor Outcome	4	accepted	EID6199 An Italian study of 163 malignant breast tumors assessed the association between PIK3CA mutations and clinical outcome. Of the 163 tumors sequenced, 118 had wild-type (wt) PIK3CA, 24 had exon 9 (helic… (full text at CIViC) PMID 17947469 · Barbareschi et al., 2007 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Prognostic	B	Does Not Support Poor Outcome	2	accepted	EID384 This study analyzed tumor and patient characteristics from 1,170 colorectal cancer patients derived from the prospective cohort studies: Nurses' Health Study and Health Professionals Follow Up Study. … (full text at CIViC) PMID 22357840 · Liao et al., 2012 · Open in CIViC	civic
Cetuximab + ChemotherapyCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Resistance	3	accepted	EID123 In chemotherapy-refractory patients with metastatic colorectal cancer and KRAS wt tumors, Exon 10 PIK3CA mutations (listed as Exon 9 in the source) had no significant impact on response rate (6/21 [28… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

PIK3CA G363A2
(oncogenic)	Malignant Head and Neck NeoplasmALIAS	Oncogenic	D	Supports Oncogenicity	3	submitted	EID7548 Whole-exome sequencing of 151 HNSCC tumours found a high frequency of mutations in PI3K pathway genes. Four novel mutation were found, including PIK3CA p.G363A. Stable transformation of HNSCC cell lin… (full text at CIViC) PMID 23619167 · Lui et al., 2013 · Open in CIViC	civic
(functional)	—UNRESOLVED	Functional	D	Supports Gain Of Function	2	submitted	EID10737 Whole-exome sequencing of 151 HNSCC tumours found a high frequency of mutations in PI3K pathway genes. Four novel mutation were found, including PIK3CA p.G363A. Stable transformation of HNSCC cell lin… (full text at CIViC) PMID 23619167 · Lui et al., 2013 · Open in CIViC	civic