PIK3CA Mutation

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Molecular profile	Therapy	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
Breast Carcinoma1
PIK3CA Mutation	Bazedoxifene + Palbociclib RegimenCombination	Predictive	B	Does Not Support Sensitivity Response	4	submitted	EID12619 In a phase Ib/II trial of bazedoxifene 40 mg daily plus palbociclib 125 mg (NCT02448771; HR positive, HER2 negative breast carcinoma; n = 36), the regimen produced a 24 week clinical benefit rate of 3… (full text at CIViC) PMID 36215125 · Tsuji et al., 2022 · Open in CIViC	civic
Glioblastoma1
PIK3CA Mutation	Buparlisib	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID7072 In this multicenter, open-label, multi-arm, phase 2 trial, 65 patients with PI3K pathway aberrations (defined by PTEN and pAKT IHC-Status in 95%, genomic testing in 5%) were treated with the PI3K inhi…

Molecular profile

Therapy

Type

Level

Direction · significance

Rating (1–5)

Status

Evidence

Source

Breast Carcinoma1

PIK3CA Mutation

Bazedoxifene + Palbociclib RegimenCombination

Predictive

Does Not Support Sensitivity Response

submitted

EID12619

In a phase Ib/II trial of bazedoxifene 40 mg daily plus palbociclib 125 mg (NCT02448771; HR positive, HER2 negative breast carcinoma; n = 36), the regimen produced a 24 week clinical benefit rate of 3… (full text at CIViC)

PMID 36215125 · Tsuji et al., 2022 · Open in CIViC

civic

Glioblastoma1

PIK3CA Mutation

Buparlisib

Predictive

Does Not Support Sensitivity Response

submitted

EID7072

In this multicenter, open-label, multi-arm, phase 2 trial, 65 patients with PI3K pathway aberrations (defined by PTEN and pAKT IHC-Status in 95%, genomic testing in 5%) were treated with the PI3K inhi…

Head and Neck Squamous Cell Carcinoma2
PIK3CA Mutation	Aspirin + Celecoxib + SulindacSubstitutes	Predictive	B	Supports Sensitivity Response	3	accepted	EID7185 In this retrospective study, the impact of nonsteroidal anti-inflammatory drugs (NSAID) on survival in PIK3CA-altered HNSCC patients (N=266) was assessed. 37 of 266 (14%) patients harbored a mutation,… (full text at CIViC) PMID 30683736 · Hedberg et al., 2019 · Open in CIViC	civic
PIK3CA Mutation	Radiation Therapy + TaselisibCombination	Predictive	D	Supports Sensitivity Response	3	accepted	EID1490 A panel of 26 HNSCC cell lines was tested for efficacy of the p110 alpha, delta and gamma isoform inhibitor taselisib (GDC-0032). Cell lines with PIK3CA mutation or amplification were the most sensiti… (full text at CIViC) PMID 26589432 · Zumsteg et al., 2016 · Open in CIViC	civic

Head and Neck Squamous Cell Carcinoma2

PIK3CA Mutation

Aspirin + Celecoxib + SulindacSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID7185

In this retrospective study, the impact of nonsteroidal anti-inflammatory drugs (NSAID) on survival in PIK3CA-altered HNSCC patients (N=266) was assessed. 37 of 266 (14%) patients harbored a mutation,… (full text at CIViC)

PMID 30683736 · Hedberg et al., 2019 · Open in CIViC

civic

PIK3CA Mutation

Radiation Therapy + TaselisibCombination

Predictive

Supports Sensitivity Response

accepted

EID1490

A panel of 26 HNSCC cell lines was tested for efficacy of the p110 alpha, delta and gamma isoform inhibitor taselisib (GDC-0032). Cell lines with PIK3CA mutation or amplification were the most sensiti… (full text at CIViC)

PMID 26589432 · Zumsteg et al., 2016 · Open in CIViC

civic

HER2-Positive Breast Carcinoma8
PIK3CA Mutation	Capecitabine + LapatinibCombination	Predictive	B	Supports Resistance	3	accepted	EID8705 In a phase 3 clinical trial (NCT00829166), metastatic HER-2 amplified breast cancer patients whose tumors harbored PIK3CA mutations treated with standard of care capecitabine and lapatinib combination… (full text at CIViC) PMID 26920887 · Baselga et al., 2016 · Open in CIViC	civic
PIK3CA Mutation	Capivasertib	Predictive	D	Supports Sensitivity Response	2	accepted	EID1504 HER2 overexpressing breast cancer cell lines with PIK3CA mutation BT474c (K111N) and HCC-1954 (H1047R) were used to establish mouse tumor xenografts. In BT474c xenografts, three dosing schedules of AZ… (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic
PIK3CA Mutation	Everolimus	Predictive	B	Supports Sensitivity Response	4	accepted	EID1296 Archival tumor samples from 549 patients from the BOLERO-1 and -3 trials were analyzed for alterations in the PI3K pathway using next-generation sequencing, immunohistochemistry (IHC) and Sanger seque… (full text at CIViC) PMID 27091708 · André et al., 2016 · Open in CIViC	civic
PIK3CA Mutation	Nab-paclitaxel	Predictive	B	Supports Resistance	2	submitted	EID13086 Targeted NGS of 17 genes was utilized to assess alterations in pre-treatment tumour biopsy samples of HER2+ breast cancers from the prospective GeparSepto (G7) trial of anti-HER2 therapy (trastuzumab/… (full text at CIViC) PMID 41974716 · Van Mackelenbergh et al., 2026 · Open in CIViC	civic
PIK3CA Mutation	Pertuzumab/Trastuzumab Regimen	Predictive	B	Supports Resistance	3	submitted	EID13085 Targeted NGS of 17 genes was utilized to assess alterations in pre-treatment tumour biopsy samples of HER2+ breast cancers from the prospective GeparSepto (G7) trial of combination trastuzumab plus pe… (full text at CIViC) PMID 41974716 · Van Mackelenbergh et al., 2026 · Open in CIViC	civic
PIK3CA Mutation	Trastuzumab	Predictive	B	Supports Resistance	2	accepted	EID1384 The HER2 overexpressing breast cancer cell line BT-474 transduced with mutant PIK3CA H1047R demonstrated essentially normal proliferation under trastuzumab, while control cells showed negligible proli… (full text at CIViC) PMID 17936563 · Berns et al., 2007 · Open in CIViC	civic
PIK3CA Mutation	Trastuzumab	Predictive	B	Supports Resistance	3	accepted	EID2098 In a retrospective study of 105 HER2-positive metastic breast cancer patients treated with trastuzumab-based therapy, the presence of a PIK3CA mutation (E542K, E545K, or H1047R) was associated with a … (full text at CIViC) PMID 21594665 · Razis et al., 2011 · Open in CIViC	civic
PIK3CA Mutation	Trastuzumab Emtansine	Predictive	B	Does Not Support Resistance	3	accepted	EID8536 In a phase 3 clinical trial (NCT00829166), metastatic HER-2 amplified breast cancer patients whose tumors harbored PIK3CA mutations treated with ado-trastuzumab emtansine (T-DM1; n=40) were associated… (full text at CIViC) PMID 26920887 · Baselga et al., 2016 · Open in CIViC	civic

HER2-Positive Breast Carcinoma8

PIK3CA Mutation

Capecitabine + LapatinibCombination

Predictive

Supports Resistance

accepted

EID8705

In a phase 3 clinical trial (NCT00829166), metastatic HER-2 amplified breast cancer patients whose tumors harbored PIK3CA mutations treated with standard of care capecitabine and lapatinib combination… (full text at CIViC)

PMID 26920887 · Baselga et al., 2016 · Open in CIViC

civic

PIK3CA Mutation

Capivasertib

Predictive

Supports Sensitivity Response

accepted

EID1504

HER2 overexpressing breast cancer cell lines with PIK3CA mutation BT474c (K111N) and HCC-1954 (H1047R) were used to establish mouse tumor xenografts. In BT474c xenografts, three dosing schedules of AZ… (full text at CIViC)

PMID 22294718 · Davies et al., 2012 · Open in CIViC

civic

PIK3CA Mutation

Everolimus

Predictive

Supports Sensitivity Response

accepted

EID1296

Archival tumor samples from 549 patients from the BOLERO-1 and -3 trials were analyzed for alterations in the PI3K pathway using next-generation sequencing, immunohistochemistry (IHC) and Sanger seque… (full text at CIViC)

PMID 27091708 · André et al., 2016 · Open in CIViC

civic

PIK3CA Mutation

Nab-paclitaxel

Predictive

Supports Resistance

submitted

EID13086

Targeted NGS of 17 genes was utilized to assess alterations in pre-treatment tumour biopsy samples of HER2+ breast cancers from the prospective GeparSepto (G7) trial of anti-HER2 therapy (trastuzumab/… (full text at CIViC)

PMID 41974716 · Van Mackelenbergh et al., 2026 · Open in CIViC

civic

PIK3CA Mutation

Pertuzumab/Trastuzumab Regimen

Predictive

Supports Resistance

submitted

EID13085

Targeted NGS of 17 genes was utilized to assess alterations in pre-treatment tumour biopsy samples of HER2+ breast cancers from the prospective GeparSepto (G7) trial of combination trastuzumab plus pe… (full text at CIViC)

PMID 41974716 · Van Mackelenbergh et al., 2026 · Open in CIViC

civic

PIK3CA Mutation

Trastuzumab

Predictive

Supports Resistance

accepted

EID1384

The HER2 overexpressing breast cancer cell line BT-474 transduced with mutant PIK3CA H1047R demonstrated essentially normal proliferation under trastuzumab, while control cells showed negligible proli… (full text at CIViC)

PMID 17936563 · Berns et al., 2007 · Open in CIViC

civic

PIK3CA Mutation

Trastuzumab

Predictive

Supports Resistance

accepted

EID2098

In a retrospective study of 105 HER2-positive metastic breast cancer patients treated with trastuzumab-based therapy, the presence of a PIK3CA mutation (E542K, E545K, or H1047R) was associated with a … (full text at CIViC)

PMID 21594665 · Razis et al., 2011 · Open in CIViC

civic

PIK3CA Mutation

Trastuzumab Emtansine

Predictive

Does Not Support Resistance

accepted

EID8536

In a phase 3 clinical trial (NCT00829166), metastatic HER-2 amplified breast cancer patients whose tumors harbored PIK3CA mutations treated with ado-trastuzumab emtansine (T-DM1; n=40) were associated… (full text at CIViC)

PMID 26920887 · Baselga et al., 2016 · Open in CIViC

civic

Lung Non-Small Cell Carcinoma2
PIK3CA Mutation	Erlotinib + GefitinibSubstitutes	Predictive	B	Supports Resistance	3	accepted	EID2355 In a retrospective study, 166 non-small cell lung cancer (NSCLC) patients that tended to have selected characteristics known to be predictive for TKI sensitivity (i.e. women, never smokers, and patien… (full text at CIViC) PMID 21258250 · Ludovini et al., 2011 · Open in CIViC	civic
PIK3CA Mutation	Taselisib	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID7400 In a phase II trial,patients with squamous NSCLC harboring PIK3CA mutations were treated with PI3K inhibitor taselisib. The study was closed for futility at interim analysis with one responder (Respon… (full text at CIViC) PMID 31158500 · Langer et al., 2019 · Open in CIViC	civic

Lung Non-Small Cell Carcinoma2

PIK3CA Mutation

Erlotinib + GefitinibSubstitutes

Predictive

Supports Resistance

accepted

EID2355

In a retrospective study, 166 non-small cell lung cancer (NSCLC) patients that tended to have selected characteristics known to be predictive for TKI sensitivity (i.e. women, never smokers, and patien… (full text at CIViC)

PMID 21258250 · Ludovini et al., 2011 · Open in CIViC

civic

PIK3CA Mutation

Taselisib

Predictive

Does Not Support Sensitivity Response

submitted

EID7400

In a phase II trial,patients with squamous NSCLC harboring PIK3CA mutations were treated with PI3K inhibitor taselisib. The study was closed for futility at interim analysis with one responder (Respon… (full text at CIViC)

PMID 31158500 · Langer et al., 2019 · Open in CIViC

civic

Malignant Breast Neoplasm11
PIK3CA Mutation	(prognostic)	Prognostic	B	Supports Better Outcome	3	accepted	EID2025 Prognostic significance of PIK3CA mutations was evaluated in a retrospective study of 590 patients with surgically resected invasive breast cancer. Patients with tumors harboring PIK3CA mutations (n=1… (full text at CIViC) PMID 19671852 · Kalinsky et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	(prognostic)	Prognostic	B	Supports Better Outcome	3	accepted	EID6188 This was a Swedish study of 270 breast tumors removed from patients with unilateral operable breast cancer, and either lymph node metastases or a tumor diameter >30mm. PIK3CA missense mutations were f… (full text at CIViC) PMID 17575221 · Pérez-Tenorio et al., 2007 · Open in CIViC	civic
PIK3CA Mutation	Alpelisib + FulvestrantCombination	Predictive	A	Supports Sensitivity Response	5	accepted	EID7313 In a phase 3 trial, patients with hormone receptor positive, HER2 receptor negative breast were allocated to alpelisib plus fulvestrant or placebo plus fulvestrant. Patients were enrolled into two coh… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
PIK3CA Mutation	Alpelisib + FulvestrantCombination	Predictive	A	Supports Sensitivity Response	5	rejected	EID7317 In a phase 3 trial, patients with hormone receptor positive, HER2 receptor negative breast were allocated to alpelisib plus fulvestrant or placebo plus fulvestrant. Patients were enrolled into two coh… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
PIK3CA Mutation	Everolimus + MTOR Kinase Inhibitor PP242Substitutes	Predictive	D	Supports Sensitivity Response	3	accepted	EID1610 A panel of 31 breast cancer cell lines was tested for sensitivity to mTORC1 inhibitor everolimus and mTORC1/mTORC2 inhibitor PP242. Inhibitor concentrations for 50% survival fraction (SF50) were measu… (full text at CIViC) PMID 21358673 · Weigelt et al., 2011 · Open in CIViC	civic
PIK3CA Mutation	Palbociclib + Phosphatidylinositide 3-Kinase InhibitorCombination	Predictive	D	Supports Sensitivity Response	3	accepted	EID1607 Three PIK3CA mutant breast cancer cell lines were rendered resistant to PI3K inhibitors (BYL719 or GDC-0941) by chronic exposure. Co-treatment of all three cell lines with PI3K inhibitor and CDK4/6 in… (full text at CIViC) PMID 25002028 · Vora et al., 2014 · Open in CIViC	civic
PIK3CA Mutation	Phosphatidylinositide 3-Kinase Inhibitor + RibociclibCombination	Predictive	D	Supports Sensitivity Response	4	accepted	EID1600 Three PI3K mutant breast cancer cell lines were rendered resistant to PI3K inhibitors (BYL719 or GDC-0941), and a panel of 42 inhibitor compounds was tested on the cells for ability to resensitize the… (full text at CIViC) PMID 25002028 · Vora et al., 2014 · Open in CIViC	civic
PIK3CA Mutation	Trastuzumab	Predictive	B	Supports Resistance	3	accepted	EID2087 In retrospective study of 175 metastatic breast cancer patients treated with trastuzumab-based therapy, the presence of a PIK3CA mutation (E542K, E545K, or H1047R) was associated with a greater risk o… (full text at CIViC) PMID 21594665 · Razis et al., 2011 · Open in CIViC	civic
PIK3CA Mutation	Trastuzumab	Predictive	C	Supports Resistance	—	rejected	EID2076 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 Mutation OR PTEN Mutation OR AKT1 Mutation	Capivasertib + FulvestrantCombination	Predictive	A	Supports Sensitivity Response	3	accepted	EID12020 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 Mutation OR RB1 Mutation OR ESR1 Mutation	Fulvestrant + PalbociclibCombination	Predictive	B	Supports Resistance	3	accepted	EID12045 In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC) PMID 30206110 · O'Leary et al., 2018 · Open in CIViC	civic

Malignant Breast Neoplasm11

PIK3CA Mutation

(prognostic)

Prognostic

Supports Better Outcome

accepted

EID2025

Prognostic significance of PIK3CA mutations was evaluated in a retrospective study of 590 patients with surgically resected invasive breast cancer. Patients with tumors harboring PIK3CA mutations (n=1… (full text at CIViC)

PMID 19671852 · Kalinsky et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

(prognostic)

Prognostic

Supports Better Outcome

accepted

EID6188

This was a Swedish study of 270 breast tumors removed from patients with unilateral operable breast cancer, and either lymph node metastases or a tumor diameter >30mm. PIK3CA missense mutations were f… (full text at CIViC)

PMID 17575221 · Pérez-Tenorio et al., 2007 · Open in CIViC

civic

PIK3CA Mutation

Alpelisib + FulvestrantCombination

Predictive

Supports Sensitivity Response

accepted

EID7313

In a phase 3 trial, patients with hormone receptor positive, HER2 receptor negative breast were allocated to alpelisib plus fulvestrant or placebo plus fulvestrant. Patients were enrolled into two coh… (full text at CIViC)

PMID 31091374 · André et al., 2019 · Open in CIViC

civic

PIK3CA Mutation

Alpelisib + FulvestrantCombination

Predictive

Supports Sensitivity Response

rejected

EID7317

PMID 31091374 · André et al., 2019 · Open in CIViC

civic

PIK3CA Mutation

Everolimus + MTOR Kinase Inhibitor PP242Substitutes

Predictive

Supports Sensitivity Response

accepted

EID1610

A panel of 31 breast cancer cell lines was tested for sensitivity to mTORC1 inhibitor everolimus and mTORC1/mTORC2 inhibitor PP242. Inhibitor concentrations for 50% survival fraction (SF50) were measu… (full text at CIViC)

PMID 21358673 · Weigelt et al., 2011 · Open in CIViC

civic

PIK3CA Mutation

Palbociclib + Phosphatidylinositide 3-Kinase InhibitorCombination

Predictive

Supports Sensitivity Response

accepted

EID1607

Three PIK3CA mutant breast cancer cell lines were rendered resistant to PI3K inhibitors (BYL719 or GDC-0941) by chronic exposure. Co-treatment of all three cell lines with PI3K inhibitor and CDK4/6 in… (full text at CIViC)

PMID 25002028 · Vora et al., 2014 · Open in CIViC

civic

PIK3CA Mutation

Phosphatidylinositide 3-Kinase Inhibitor + RibociclibCombination

Predictive

Supports Sensitivity Response

accepted

EID1600

Three PI3K mutant breast cancer cell lines were rendered resistant to PI3K inhibitors (BYL719 or GDC-0941), and a panel of 42 inhibitor compounds was tested on the cells for ability to resensitize the… (full text at CIViC)

PMID 25002028 · Vora et al., 2014 · Open in CIViC

civic

PIK3CA Mutation

Trastuzumab

Predictive

Supports Resistance

accepted

EID2087

In retrospective study of 175 metastatic breast cancer patients treated with trastuzumab-based therapy, the presence of a PIK3CA mutation (E542K, E545K, or H1047R) was associated with a greater risk o… (full text at CIViC)

PMID 21594665 · Razis et al., 2011 · Open in CIViC

civic

PIK3CA Mutation

Trastuzumab

Predictive

Supports Resistance

—

rejected

EID2076

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 Mutation OR PTEN Mutation OR AKT1 Mutation

Capivasertib + FulvestrantCombination

Predictive

Supports Sensitivity Response

accepted

EID12020

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 Mutation OR RB1 Mutation OR ESR1 Mutation

Fulvestrant + PalbociclibCombination

Predictive

Supports Resistance

accepted

EID12045

In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC)

PMID 30206110 · O'Leary et al., 2018 · Open in CIViC

civic

Malignant Colorectal Neoplasm15
PIK3CA Mutation	(prognostic)	Prognostic	B	Supports Poor Outcome	3	accepted	EID2105 This retrospective study examines outcomes of 158 primary sporadic colorectal cancer patients who had undergone surgical resection and were treated with 5-fluorouracil based chemotherapy. PIK3CA mutat… (full text at CIViC) PMID 17590872 · Kato et al., 2007 · Open in CIViC	civic
PIK3CA Mutation	(prognostic)	Prognostic	B	Does Not Support Poor Outcome	3	accepted	EID6297 This was a retrospective clinical study of 168 metastatic colorectal cancer patients who received first line chemotherapy (made up of 5-fluorouracil (5-FU) only, 5-FU + oxaliplatin, 5-FU + irinotecan,… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	Anti-EGFR Monoclonal Antibody	Predictive	B	Supports Resistance	4	accepted	EID915 A meta-analysis of 8 metastatic colorectal cancer studies (839 patients) was performed. PIK3CA mutations were significantly associated with shorter PFS and OS following therapy with anti-EGFR monoclon… (full text at CIViC) PMID 23435830 · Wu et al., 2013 · Open in CIViC	civic
PIK3CA Mutation	Aspirin	Predictive	B	Supports Sensitivity Response	3	accepted	EID6375 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
PIK3CA Mutation	Aspirin	Predictive	B	Supports Sensitivity Response	3	rejected	EID7187 In this retrospective study in 964 patients with colorectal cancer (CRC), the regular use of aspirin after diagnosis was significantly associated with cancer-specific (HR 0.18, p<0.001) and overall su… (full text at CIViC) PMID 23094721 · Liao et al., 2012 · Open in CIViC	civic
PIK3CA Mutation	Bevacizumab	Predictive	B	Does Not Support Resistance	3	accepted	EID6300 This was a retrospective clinical study of 97 metastatic colorectal cancer patients who received bevacizumab in conjunction with first-line chemotherapy (composed of 5-fluorouracil (5-FU) only, 5-FU +… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	Cabozantinib	Predictive	D	Supports Sensitivity Response	3	accepted	EID771 20 patient-derived colorectal cancer xenografts were treated with cabozantinib, a c-MET and VEGFR2 inhibitor. 16 xenografts showed sensitivity (as defined by TGII: tumor growth of treated compared to … (full text at CIViC) PMID 25242168 · Song et al., 2015 · Open in CIViC	civic
PIK3CA Mutation	Cetuximab	Predictive	B	Supports Resistance	3	accepted	EID6301 This was a retrospective clinical study of 92 metastatic colorectal cancer patients who received cetuximab in conjunction with salvage chemotherapy (refractory to at least one line of treatment). Salv… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	Cetuximab	Predictive	D	Supports Resistance	1	accepted	EID1705 A cohort of patient-derived xenografts (PDX) from 85 patients with metastatic colorectal cancer was created. PDX were treated with cetuximab and mechanisms of resistance investigated. None of the xeno… (full text at CIViC) PMID 22586653 · Bertotti et al., 2011 · Open in CIViC	civic
PIK3CA Mutation	Cetuximab + ChemotherapyCombination	Predictive	B	Does Not Support Resistance	2	accepted	EID3732 This was a retrospective study of 605 patients with metastatic, chemotherapy refractory colorectal cancer treated with cetuximab + chemotherapy. Patients with KRAS wildtype, PIK3CA assessable tumors, … (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
PIK3CA Mutation	Irinotecan	Predictive	B	Does Not Support Resistance	3	accepted	EID6299 This was a retrospective clinical study of 44 metastatic colorectal cancer patients who received FOLFIRI (5-Fluorouacil + Folinic acid + irinotecan) first-line therapy alone or with bevacizumab. It as… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	Oxaliplatin	Predictive	B	Does Not Support Resistance	3	accepted	EID6298 This was a retrospective clinical study of 100 metastatic colorectal cancer patients who received FOLFOX (oxaliplatin + 5-fluorouracil + folinic acid) first-line therapy alone or with monoclonal antib… (full text at CIViC) PMID 19603024 · Souglakos et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	Cetuximab + PanitumumabSubstitutes	Predictive	B	Supports Resistance	3	accepted	EID6362 Mutational analysis of 110 metastatic colorectal cancer patients was used to examine objective tumor response, progression free survival (PFS), and overall survival (OS) following treatment with anti-… (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
PIK3CA Mutation	PD-1 Ligand Inhibitor	Predictive	D	Supports Resistance	2	submitted	EID12362 In the transplantable MC38 colon carcinoma cell line, expression of PIK3CA:p.H1047R (or constructs with similar function) confers survival advantage under PD-1 blockade compared with wildtype, which c… (full text at CIViC) PMID 35264433 · Collins et al., 2022 · Open in CIViC	civic
PIK3CA Mutation OR PTEN Mutation OR PIK3R1 Mutation	Aspirin	Predictive	B	Supports Sensitivity Response	4	accepted	EID12602 In a randomized, double blind, placebo controlled adjuvant trial in colorectal carcinoma with PI3K pathway mutations (ALASCCA, NCT02647099; group B n = 312), aspirin 160 mg daily (group B n = 156) for… (full text at CIViC) PMID 40961426 · Martling et al., 2025 · Open in CIViC	civic

Malignant Colorectal Neoplasm15

PIK3CA Mutation

(prognostic)

Prognostic

Supports Poor Outcome

accepted

EID2105

This retrospective study examines outcomes of 158 primary sporadic colorectal cancer patients who had undergone surgical resection and were treated with 5-fluorouracil based chemotherapy. PIK3CA mutat… (full text at CIViC)

PMID 17590872 · Kato et al., 2007 · Open in CIViC

civic

PIK3CA Mutation

(prognostic)

Prognostic

Does Not Support Poor Outcome

accepted

EID6297

This was a retrospective clinical study of 168 metastatic colorectal cancer patients who received first line chemotherapy (made up of 5-fluorouracil (5-FU) only, 5-FU + oxaliplatin, 5-FU + irinotecan,… (full text at CIViC)

PMID 19603024 · Souglakos et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

Anti-EGFR Monoclonal Antibody

Predictive

Supports Resistance

accepted

EID915

A meta-analysis of 8 metastatic colorectal cancer studies (839 patients) was performed. PIK3CA mutations were significantly associated with shorter PFS and OS following therapy with anti-EGFR monoclon… (full text at CIViC)

PMID 23435830 · Wu et al., 2013 · Open in CIViC

civic

PIK3CA Mutation

Aspirin

Predictive

Supports Sensitivity Response

accepted

EID6375

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

PIK3CA Mutation

Aspirin

Predictive

Supports Sensitivity Response

rejected

EID7187

In this retrospective study in 964 patients with colorectal cancer (CRC), the regular use of aspirin after diagnosis was significantly associated with cancer-specific (HR 0.18, p<0.001) and overall su… (full text at CIViC)

PMID 23094721 · Liao et al., 2012 · Open in CIViC

civic

PIK3CA Mutation

Bevacizumab

Predictive

Does Not Support Resistance

accepted

EID6300

This was a retrospective clinical study of 97 metastatic colorectal cancer patients who received bevacizumab in conjunction with first-line chemotherapy (composed of 5-fluorouracil (5-FU) only, 5-FU +… (full text at CIViC)

PMID 19603024 · Souglakos et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

Cabozantinib

Predictive

Supports Sensitivity Response

accepted

EID771

20 patient-derived colorectal cancer xenografts were treated with cabozantinib, a c-MET and VEGFR2 inhibitor. 16 xenografts showed sensitivity (as defined by TGII: tumor growth of treated compared to … (full text at CIViC)

PMID 25242168 · Song et al., 2015 · Open in CIViC

civic

PIK3CA Mutation

Cetuximab

Predictive

Supports Resistance

accepted

EID6301

This was a retrospective clinical study of 92 metastatic colorectal cancer patients who received cetuximab in conjunction with salvage chemotherapy (refractory to at least one line of treatment). Salv… (full text at CIViC)

PMID 19603024 · Souglakos et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

Cetuximab

Predictive

Supports Resistance

accepted

EID1705

A cohort of patient-derived xenografts (PDX) from 85 patients with metastatic colorectal cancer was created. PDX were treated with cetuximab and mechanisms of resistance investigated. None of the xeno… (full text at CIViC)

PMID 22586653 · Bertotti et al., 2011 · Open in CIViC

civic

PIK3CA Mutation

Cetuximab + ChemotherapyCombination

Predictive

Does Not Support Resistance

accepted

EID3732

This was a retrospective study of 605 patients with metastatic, chemotherapy refractory colorectal cancer treated with cetuximab + chemotherapy. Patients with KRAS wildtype, PIK3CA assessable tumors, … (full text at CIViC)

PMID 20619739 · De Roock et al., 2010 · Open in CIViC

civic

PIK3CA Mutation

Irinotecan

Predictive

Does Not Support Resistance

accepted

EID6299

This was a retrospective clinical study of 44 metastatic colorectal cancer patients who received FOLFIRI (5-Fluorouacil + Folinic acid + irinotecan) first-line therapy alone or with bevacizumab. It as… (full text at CIViC)

PMID 19603024 · Souglakos et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

Oxaliplatin

Predictive

Does Not Support Resistance

accepted

EID6298

This was a retrospective clinical study of 100 metastatic colorectal cancer patients who received FOLFOX (oxaliplatin + 5-fluorouracil + folinic acid) first-line therapy alone or with monoclonal antib… (full text at CIViC)

PMID 19603024 · Souglakos et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

Cetuximab + PanitumumabSubstitutes

Predictive

Supports Resistance

accepted

EID6362

Mutational analysis of 110 metastatic colorectal cancer patients was used to examine objective tumor response, progression free survival (PFS), and overall survival (OS) following treatment with anti-… (full text at CIViC)

PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC

civic

PIK3CA Mutation

PD-1 Ligand Inhibitor

Predictive

Supports Resistance

submitted

EID12362

In the transplantable MC38 colon carcinoma cell line, expression of PIK3CA:p.H1047R (or constructs with similar function) confers survival advantage under PD-1 blockade compared with wildtype, which c… (full text at CIViC)

PMID 35264433 · Collins et al., 2022 · Open in CIViC

civic

PIK3CA Mutation OR PTEN Mutation OR PIK3R1 Mutation

Aspirin

Predictive

Supports Sensitivity Response

accepted

EID12602

In a randomized, double blind, placebo controlled adjuvant trial in colorectal carcinoma with PI3K pathway mutations (ALASCCA, NCT02647099; group B n = 312), aspirin 160 mg daily (group B n = 156) for… (full text at CIViC)

PMID 40961426 · Martling et al., 2025 · Open in CIViC

civic

Malignant Endometrial Neoplasm2
PIK3CA Mutation	Pictilisib	Predictive	D	Supports Sensitivity Response	3	accepted	EID1616 A panel of 24 endometrioid endometrial cancer (EEC) cell lines was characterized for a set of mutations and sensitivity to pan PI3K class I inhibitor GDC-0941 (pictilisib) was assessed. EEC cell lines… (full text at CIViC) PMID 23674493 · Weigelt et al., 2013 · Open in CIViC	civic
PIK3CA Mutation	Ridaforolimus + TemsirolimusSubstitutes	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID892 94 endometrial cancer samples of women who had been treated with single agent mTOR inhibitors temsirolimus or ridaforolimus were retrospectively analyzed. No predictive biomarkers were identified, inc… (full text at CIViC) PMID 24166148 · Mackay et al., 2014 · Open in CIViC	civic

Malignant Endometrial Neoplasm2

PIK3CA Mutation

Pictilisib

Predictive

Supports Sensitivity Response

accepted

EID1616

A panel of 24 endometrioid endometrial cancer (EEC) cell lines was characterized for a set of mutations and sensitivity to pan PI3K class I inhibitor GDC-0941 (pictilisib) was assessed. EEC cell lines… (full text at CIViC)

PMID 23674493 · Weigelt et al., 2013 · Open in CIViC

civic

PIK3CA Mutation

Ridaforolimus + TemsirolimusSubstitutes

Predictive

Does Not Support Sensitivity Response

accepted

EID892

94 endometrial cancer samples of women who had been treated with single agent mTOR inhibitors temsirolimus or ridaforolimus were retrospectively analyzed. No predictive biomarkers were identified, inc… (full text at CIViC)

PMID 24166148 · Mackay et al., 2014 · Open in CIViC

civic

Malignant Gastric Neoplasm1
PIK3CA Mutation	Capivasertib	Predictive	D	Supports Sensitivity Response	3	accepted	EID1501 In a panel of 22 gastric cancer cell lines, 4 of 6 cell lines having the highest sensitivity to AZD5363 contained a PIK3CA mutation (E542K, E453K, E545K). A patient derived gastric cancer xenograft mo… (full text at CIViC) PMID 24088382 · Li et al., 2013 · Open in CIViC	civic

Malignant Gastric Neoplasm1

PIK3CA Mutation

Capivasertib

Predictive

Supports Sensitivity Response

accepted

EID1501

In a panel of 22 gastric cancer cell lines, 4 of 6 cell lines having the highest sensitivity to AZD5363 contained a PIK3CA mutation (E542K, E453K, E545K). A patient derived gastric cancer xenograft mo… (full text at CIViC)

PMID 24088382 · Li et al., 2013 · Open in CIViC

civic

Malignant Head and Neck Neoplasm2
PIK3CA Mutation	Dactolisib	Predictive	D	Supports Sensitivity Response	3	accepted	EID1360 Preclinical analysis of the predicitive value of PIK3CA mutations for mTOR/PI3K Inhibition with BEZ-235. Two cell lines with PIK3CA Mutation (H1047R) were more sensitive to BEZ-235 than two cell lines… (full text at CIViC) PMID 23619167 · Lui et al., 2013 · Open in CIViC	civic
PIK3CA Mutation	Pictilisib + Tanespimycin + TrametinibSubstitutes	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID1364 6 head and neck cancer cell lines were tested for Response to 17-AAG, GDC-0941. Two of the cell lines did not carry PIK3CA mutations. No clear difference was shown between PIK3CA-mutant and wild-type … (full text at CIViC) PMID 25855885 · Wirtz et al., 2015 · Open in CIViC	civic

Malignant Head and Neck Neoplasm2

PIK3CA Mutation

Dactolisib

Predictive

Supports Sensitivity Response

accepted

EID1360

Preclinical analysis of the predicitive value of PIK3CA mutations for mTOR/PI3K Inhibition with BEZ-235. Two cell lines with PIK3CA Mutation (H1047R) were more sensitive to BEZ-235 than two cell lines… (full text at CIViC)

PMID 23619167 · Lui et al., 2013 · Open in CIViC

civic

PIK3CA Mutation

Pictilisib + Tanespimycin + TrametinibSubstitutes

Predictive

Does Not Support Sensitivity Response

accepted

EID1364

6 head and neck cancer cell lines were tested for Response to 17-AAG, GDC-0941. Two of the cell lines did not carry PIK3CA mutations. No clear difference was shown between PIK3CA-mutant and wild-type … (full text at CIViC)

PMID 25855885 · Wirtz et al., 2015 · Open in CIViC

civic

Malignant Neoplasm5
PIK3CA Mutation	Alpelisib	Predictive	D	Supports Sensitivity Response	4	accepted	EID1402 A set of 474 cell lines from the Cancer Cell Line Encyclopedia was tested for responsiveness to the PI3Kalpha specific inhibitor BYL719 (Alpelisib). In the PIK3CA wild type subroup of cell lines, 22% … (full text at CIViC) PMID 24608574 · Fritsch et al., 2014 · Open in CIViC	civic
PIK3CA Mutation	Capivasertib	Predictive	B	Supports Sensitivity Response	4	accepted	EID3040 In a study of 37 patients with AKT1 (E13K) mutations, 5 patients harbored a concurrent PI3K/mTOR pathway alteration. The PFS of patients with a concurrent PI3K/mTOR pathway alteration was significantl… (full text at CIViC) PMID 28489509 · Hyman et al., 2017 · Open in CIViC	civic
PIK3CA Mutation	Capivasertib	Predictive	D	Supports Sensitivity Response	3	accepted	EID1503 Sensitivity to pan-Akt inhibitor AZD5363 was assessed in a panel of 182 cell lines (160 with PTEN evaluated) derived from solid and hematological tumors. PTEN loss of function due to loss or mutation … (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic
PIK3CA Mutation	Copanlisib	Predictive	B	Supports Sensitivity Response	3	accepted	EID11678 In this NCI-MATCH trial subprotocol Z1F, of the 35 patients enrolled harbouring PIK3CA mutations in their tumors, 25 were included in the primary efficacy analysis and treated with copanlisib. Patient… (full text at CIViC) PMID 35133871 · Damodaran et al., 2022 · Open in CIViC	civic
PIK3CA Mutation	Pictilisib + TanespimycinSubstitutes	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID1358 Analysis of drug response data from the Sanger center cell line screen. Cell lines with either PI3K and/or PTEN mutations did not show a significant difference in response to class I PI3K inhibitor GD… (full text at CIViC) PMID 25855885 · Wirtz et al., 2015 · Open in CIViC	civic

Malignant Neoplasm5

PIK3CA Mutation

Alpelisib

Predictive

Supports Sensitivity Response

accepted

EID1402

A set of 474 cell lines from the Cancer Cell Line Encyclopedia was tested for responsiveness to the PI3Kalpha specific inhibitor BYL719 (Alpelisib). In the PIK3CA wild type subroup of cell lines, 22% … (full text at CIViC)

PMID 24608574 · Fritsch et al., 2014 · Open in CIViC

civic

PIK3CA Mutation

Capivasertib

Predictive

Supports Sensitivity Response

accepted

EID3040

In a study of 37 patients with AKT1 (E13K) mutations, 5 patients harbored a concurrent PI3K/mTOR pathway alteration. The PFS of patients with a concurrent PI3K/mTOR pathway alteration was significantl… (full text at CIViC)

PMID 28489509 · Hyman et al., 2017 · Open in CIViC

civic

PIK3CA Mutation

Capivasertib

Predictive

Supports Sensitivity Response

accepted

EID1503

Sensitivity to pan-Akt inhibitor AZD5363 was assessed in a panel of 182 cell lines (160 with PTEN evaluated) derived from solid and hematological tumors. PTEN loss of function due to loss or mutation … (full text at CIViC)

PMID 22294718 · Davies et al., 2012 · Open in CIViC

civic

PIK3CA Mutation

Copanlisib

Predictive

Supports Sensitivity Response

accepted

EID11678

In this NCI-MATCH trial subprotocol Z1F, of the 35 patients enrolled harbouring PIK3CA mutations in their tumors, 25 were included in the primary efficacy analysis and treated with copanlisib. Patient… (full text at CIViC)

PMID 35133871 · Damodaran et al., 2022 · Open in CIViC

civic

PIK3CA Mutation

Pictilisib + TanespimycinSubstitutes

Predictive

Does Not Support Sensitivity Response

accepted

EID1358

Analysis of drug response data from the Sanger center cell line screen. Cell lines with either PI3K and/or PTEN mutations did not show a significant difference in response to class I PI3K inhibitor GD… (full text at CIViC)

PMID 25855885 · Wirtz et al., 2015 · Open in CIViC

civic

Evidence by cancer (54 items)

Clinical significance (0)