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 251–298 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 Mutation5
Trastuzumab	Malignant Breast Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID2087

Cohorts

Alteration frequency by cohort (200)

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

gdcObserved200 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
Lung Squamous Cell Carcinoma TCGA-LUSC	Lung Squamous Cell Carcinoma

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 N345K2
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	3	submitted	EID12182 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	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	1	accepted	EID4047 Three patients participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored PIK3CA N345K, were wildtype for KRAS, BRAF and … (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic

PIK3CA Overexpression5
Dactolisib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID8269 In a preclinical study, efficacy of NVP-BEZ235 (dactolisib) monotherapy was evaluated in vitro against HER2 amplified breast cancer cell line BT474 with retrovirally induced PIK3CA amplification. Auth… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Lapatinib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID8268 In a preclinical study, efficacy of lapatinib monotherapy was evaluated in vitro against HER2 amplified breast cancer cell lines (BT474 and SKBR3) with retrovirally induced PIK3CA expression. Authors … (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Lapatinib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID8270 In a preclinical study, efficacy of lapatinib and trastuzumab combination therapy was evaluated in vitro against HER2 amplified breast cancer cell lines (BT474 and SKBR3) with retrovirally induced PIK… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Trastuzumab	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	2	accepted	EID8267 HER2-positive breast cancer cell lines (BT-474 and SKBR3) were retrovirally transduced with wildtype PIK3CA and treated with trastuzumab. PIK3CA overexpression diminished the growth inhibitory effects… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Vemurafenib	Melanoma	Predictive	D	Supports Resistance	3	rejected	EID6265 An in vitro study of M229 (a human melanoma cell line) endogenously expressing wildtype PIK3CA and BRAF V600E (a known BRAF inhibitor sensitizing mutation) found that cells induced to stably over-expr… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic

PIK3CA Q546E2
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12190 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
PI103	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	—	submitted	EID2090 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 Q546K4
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12191 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	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	rejected	EID3727 In a retrospective study of 168 chemotherapy-refractory metastatic colorectal cancer patients, patients with a PIK3CA mutation (n=26) treated with cetuximab in combination with standard chemotherapy, … (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Does Not Support Resistance	2	accepted	EID2198 One patient participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored PIK3CA Q546K (exon 10), was wildtype for KRAS, BR… (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	EID2079 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 Q546P2
(functional)	—UNRESOLVED	Functional	D	Supports Gain Of Function	3	submitted	EID7695 The rare PIK3CA mutation Q546P was shown to have strong oncogenic transforming abilities when expressed in chicken embryo fibroblasts (CEF), similar to levels seen for hotspot PIK3CA mutations. The Q5… (full text at CIViC) PMID 17376864 · Gymnopoulos et al., 2007 · Open in CIViC	civic
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12192 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

PIK3CA Q546R2
(oncogenic)	Malignant Breast Neoplasm	Oncogenic	D	Supports Oncogenicity	4	submitted	EID7723 Recurrent PIK3CA mutations detected in breast cancer were evaluated by in vitro and in vivo growth and transformation assays. The PIK3CA mutation Q546R was found in 16 samples from COSMIC. Expression … (full text at CIViC) PMID 26627007 · Dogruluk et al., 2015 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Oncogenic	D	Supports Oncogenicity	4	rejected	EID10810 Recurrent PIK3CA mutations detected in breast cancer were evaluated by in vitro and in vivo growth and transformation assays. The PIK3CA mutation Q546R was found in 16 samples from COSMIC. Expression … (full text at CIViC) PMID 26627007 · Dogruluk et al., 2015 · Open in CIViC	civic

PIK3CA Rare Mutation2
(prognostic)	Malignant Breast Neoplasm	Prognostic	B	Supports Better Outcome	2	accepted	EID2042 Prognostic significance of PIK3CA mutations was evaluated in a retrospective study of 590 patients with surgically resected invasive breast cancer. Tumors harboring rare PIK3CA mutations (N345K: 2.4%,… (full text at CIViC) PMID 19671852 · Kalinsky et al., 2009 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Prognostic	B	Supports Better Outcome	2	rejected	EID8915 Prognostic significance of PIK3CA mutations was evaluated in a retrospective study of 590 patients with surgically resected invasive breast cancer. Tumors harboring rare PIK3CA mutations (N345K: 2.4%,… (full text at CIViC) PMID 19671852 · Kalinsky et al., 2009 · Open in CIViC	civic

PIK3CA Wildtype2
Aspirin	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID2038 This was a retrospective study of 964 colorectal cancer patients who participated in the Nurses' Health Study and the Health Professionals Follow-up Study. Of 964 patients, 803 patients had wildtype P… (full text at CIViC) PMID 23094721 · Liao et al., 2012 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	rejected	EID7047 This was a retrospective study of 964 colorectal cancer patients who participated in the Nurses' Health Study and the Health Professionals Follow-up Study. Of 964 patients, 803 patients had wildtype P… (full text at CIViC) PMID 23094721 · Liao et al., 2012 · Open in CIViC	civic