| PIK3CA Mutation45 |
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| (prognostic) | Malignant Breast Neoplasm | Prognostic | B | Supports Better Outcome | 3 | accepted | EID2025Prognostic 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 |
| 〃 | Malignant Colorectal NeoplasmCURATED_BROADER | Prognostic | B | Supports Poor Outcome | 3 | accepted | EID2105This 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 |
| 〃 | Malignant Breast Neoplasm | Prognostic | B | Supports Better Outcome | 3 | accepted | EID6188This 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 |
| 〃 | Malignant Colorectal NeoplasmCURATED_BROADER | Prognostic | B | Does Not Support Poor Outcome | 3 | accepted | EID6297This 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 |
| Akt Inhibitor MK2206 | Malignant Thyroid Gland Neoplasm | Predictive | D | Supports Sensitivity Response | 2 | submitted | EID12720In thyroid cancer cell lines, MK2206 selectively inhibited the proliferation of cells harboring PI3K/Akt pathway activating mutations (PIK3CA, PTEN, RAS or RET/PTC) with IC50 values mostly below or ar… (full text at CIViC) PMID 21289267 · Liu et al., 2011 · Open in CIViC | civic |
| Alpelisib | Malignant NeoplasmALIAS | Predictive | D | Supports Sensitivity Response | 4 | accepted | EID1402A 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 |
| Alpelisib + FulvestrantCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 5 | accepted | EID7313In 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 |
| 〃 | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 5 | rejected | EID7317In 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 |
| Anti-EGFR Monoclonal Antibody | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Supports Resistance | 4 | accepted | EID915A 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 |
| Aspirin | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Supports Sensitivity Response | 3 | accepted | EID6375This 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 | Supports Sensitivity Response | 3 | rejected | EID7187In 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 |
| Aspirin + Celecoxib + SulindacSubstitutes | Head and Neck Squamous Cell Carcinoma | Predictive | B | Supports Sensitivity Response | 3 | accepted | EID7185In 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 |
| Bazedoxifene + Palbociclib RegimenCombination | Breast Carcinoma | Predictive | B | Does Not Support Sensitivity Response | 4 | submitted | EID12619In 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 |
| Bevacizumab | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Does Not Support Resistance | 3 | accepted | EID6300This 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 |
| Buparlisib | GlioblastomaCURATED_BROADER | Predictive | B | Does Not Support Sensitivity Response | 3 | submitted | EID7072In 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… (full text at CIViC) PMID 30715997 · Wen et al., 2019 · Open in CIViC | civic |
| Cabozantinib | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID77120 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 |
| Capecitabine + LapatinibCombination | HER2-Positive Breast CarcinomaALIAS | Predictive | B | Supports Resistance | 3 | accepted | EID8705In 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 |
| Capivasertib | Malignant NeoplasmALIAS | Predictive | B | Supports Sensitivity Response | 4 | accepted | EID3040In 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 |
| 〃 | Malignant Gastric Neoplasm | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1501In 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 NeoplasmALIAS | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1503Sensitivity 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 |
| 〃 | HER2-Positive Breast CarcinomaALIAS | Predictive | D | Supports Sensitivity Response | 2 | accepted | EID1504HER2 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 |
| Cetuximab | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Supports Resistance | 3 | accepted | EID6301This 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 |
| 〃 | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | D | Supports Resistance | 1 | accepted | EID1705A 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 |
| Cetuximab + ChemotherapyCombination | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Does Not Support Resistance | 2 | accepted | EID3732This 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 |
| Copanlisib | Malignant NeoplasmALIAS | Predictive | B | Supports Sensitivity Response | 3 | accepted | EID11678In 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 |
| Dactolisib | Malignant Head and Neck NeoplasmALIAS | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1360Preclinical 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 |
| Everolimus | HER2-Positive Breast CarcinomaALIAS | Predictive | B | Supports Sensitivity Response | 4 | accepted | EID1296Archival 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 |
| Everolimus + MTOR Kinase Inhibitor PP242Substitutes | Malignant Breast Neoplasm | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1610A 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 |
| Erlotinib + GefitinibSubstitutes | Lung Non-Small Cell CarcinomaCURATED_BROADER | Predictive | B | Supports Resistance | 3 | accepted | EID2355In 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 |
| Irinotecan | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Does Not Support Resistance | 3 | accepted | EID6299This 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 |
| Nab-paclitaxel | HER2-Positive Breast CarcinomaALIAS | Predictive | B | Supports Resistance | 2 | submitted | EID13086Targeted 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 |
| Oxaliplatin | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Does Not Support Resistance | 3 | accepted | EID6298This 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 |
| Cetuximab + PanitumumabSubstitutes | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | B | Supports Resistance | 3 | accepted | EID6362Mutational 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 |
| PD-1 Ligand Inhibitor | Malignant Colorectal NeoplasmCURATED_BROADER | Predictive | D | Supports Resistance | 2 | submitted | EID12362In 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 |
| Pertuzumab/Trastuzumab Regimen | HER2-Positive Breast CarcinomaALIAS | Predictive | B | Supports Resistance | 3 | submitted | EID13085Targeted 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 |
| Palbociclib + Phosphatidylinositide 3-Kinase InhibitorCombination | Malignant Breast Neoplasm | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1607Three 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 |
| Pictilisib | Malignant Endometrial NeoplasmCURATED_BROADER | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1616A 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 |
| Radiation Therapy + TaselisibCombination | Head and Neck Squamous Cell Carcinoma | Predictive | D | Supports Sensitivity Response | 3 | accepted | EID1490A 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 |
| Phosphatidylinositide 3-Kinase Inhibitor + RibociclibCombination | Malignant Breast Neoplasm | Predictive | D | Supports Sensitivity Response | 4 | accepted | EID1600Three 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 |
| Tamoxifen | Estrogen Receptor-positive Breast CancerUNRESOLVED | Predictive | B | Does Not Support Sensitivity Response | 3 | accepted | EID6189This 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 |
| Pictilisib + TanespimycinSubstitutes | Malignant NeoplasmALIAS | Predictive | D | Does Not Support Sensitivity Response | 2 | accepted | EID1358Analysis 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 |
| Pictilisib + Tanespimycin + TrametinibSubstitutes | Malignant Head and Neck NeoplasmALIAS | Predictive | D | Does Not Support Sensitivity Response | 2 | accepted | EID13646 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 |
| Taselisib | Lung Non-Small Cell CarcinomaCURATED_BROADER | Predictive | B | Does Not Support Sensitivity Response | 3 | submitted | EID7400In 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 NeoplasmALIAS | Predictive | C | Does Not Support Sensitivity Response | 3 | accepted | EID11679In this phase II NCI-MATCH trial subprotocol I, 61 patients harbouring activating PIK3CA mutations were treated with taselisib. The cohort didn't include any patients with breast or squamous cell lung… (full text at CIViC) PMID 35138919 · Krop et al., 2022 · Open in CIViC | civic |
| Ridaforolimus + TemsirolimusSubstitutes | Malignant Endometrial NeoplasmCURATED_BROADER | Predictive | B | Does Not Support Sensitivity Response | 3 | accepted | EID89294 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 |