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BIOMARKER:

PIK3CA mutation

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Other names: PIK3CA, Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, Phosphoinositide-3-kinase, catalytic, alpha polypeptide, Serine/threonine protein kinase PIK3CA, PtdIns-3-kinase subunit P110-alpha, PI3K-alpha, Phosphatidylinositol-4,5-bisphosphate 3-kinase 110 KDa catalytic subunit alpha, Phosphatidylinositol 3-kinase, Catalytic, 110-KD, alpha, PI3-kinase P110 subunit alpha, PI3-kinase subunit alpha, PtdIns-3-kinase subunit alpha, PI3Kalpha, P110alpha, PI3K
Entrez ID:
Related biomarkers:
Related tests:
1d
Circulating cell-free DNA as an integrative biomarker in breast cancer: correlation with molecular subtypes, mutation status, and treatment response. (PubMed, Front Oncol)
cfDNA trends across subtypes range from persistent elevation in TNBC to decline in Luminal A, suggesting its potential role in treatment monitoring. These findings underscore cfDNA's relevance to evolving precision oncology frameworks, particularly in biopsy-limited and resource-constrained settings.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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TP53 mutation • PIK3CA mutation
1d
Demographics, clinicopathological features, and survival outcomes of women with endometrial neuroendocrine tumors. (PubMed, Gynecol Oncol)
ENETs are rare, aggressive tumors often diagnosed at an advanced stage. Combined adjuvant chemotherapy and radiotherapy were associated with improved outcomes. Molecular profiling may identify potential therapeutic targets.
Journal
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A) • MLH1 (MutL homolog 1) • PMS2 (PMS1 protein homolog 2)
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MSI-H/dMMR • PIK3CA mutation • PTEN mutation • ARID1A mutation
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cisplatin • carboplatin • paclitaxel • etoposide IV
2d
Highlighting the molecular refinement of NSMP endometrial cancer in a case of mesonephric-like adenocarcinoma. (PubMed, Gynecol Oncol Rep)
The patient therefore underwent adjuvant carboplatin/paclitaxel chemotherapy followed by vaginal brachytherapy and has remained recurrence-free for five years. This case demonstrates molecular classification of an unusual histological type of EC exhibiting an extremely short-term risk of early distant metastasis and its implication on aggressive adjuvant therapeutical approach. It, furthermore, exemplifies the pronounced heterogeneity of the NSMP subgroup.
Journal
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KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • L1CAM (L1 cell adhesion molecule)
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KRAS mutation • PIK3CA mutation • PTEN mutation • ER negative
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carboplatin • paclitaxel
3d
NCI-2022-06209: Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (clinicaltrials.gov)
P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
Trial completion date
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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PIK3CA mutation
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Aliqopa (copanlisib)
3d
Case Report: Membranous/cytoplasmic Ki-67 staining and PAX8-GLIS3 fusion: defining the clinicopathological spectrum of hyalinizing trabecular tumor to optimize patient management. (PubMed, Front Med (Lausanne))
The use of Ki-67 immunohistochemistry or PAX8-GLIS3 testing on cytological specimens can aid in definitive diagnosis and prevent unnecessary surgery. Thus, an integrated approach combining cytological, histological, immunohistochemical, and molecular data is essential for the accurate diagnosis and optimal clinical management of HTT.
Journal
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • TTF1 (Transcription Termination Factor 1) • NCAM1 (Neural cell adhesion molecule 1) • NKX2-1 (NK2 Homeobox 1) • PAX8 (Paired box 8)
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BRAF mutation • PIK3CA mutation
4d
GOG-3069: A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (clinicaltrials.gov)
P2, N=51, Active, not recruiting, GOG Foundation | Recruiting --> Active, not recruiting | Trial completion date: Apr 2026 --> Nov 2028 | Trial primary completion date: Apr 2025 --> May 2028
Enrollment closed • Trial completion date • Trial primary completion date
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ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
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PIK3CA mutation
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Piqray (alpelisib) • fulvestrant
5d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
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HER-2 amplification • HER-2 negative • PIK3CA mutation • HER-2 negative + HR negative
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Halaven (eribulin mesylate) • Itovebi (inavolisib)
5d
Exploratory biomarker findings from regorafenib plus toripalimab in patients with refractory metastatic colorectal cancer (REGOTORI study). (PubMed, Gastroenterol Rep (Oxf))
High positive rates of CD3+, CD3+CD8+, CD3+CD8-, and PD-1+CD3+ T cells in the stroma area correlated with prolonged progression-free survival and favorable disease control; however, neither the positive rate of PD-L1 cells nor the density of it in the tumor area was associated with survival and response. In this combination-therapy-focused multi-omics analysis integrating tissue genomics, ctDNA features/dynamics and TME profiling, we identified ctDNA maxAF, HAF-bTMB, bITH, HAF-bITH, mutational status of SMAD4 or PIK3CA and TME markers as predictive or prognostic biomarkers for regorafenib plus toripalimab in refractory mCRC.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • SMAD4 (SMAD family member 4)
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PIK3CA mutation
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Loqtorzi (toripalimab-tpzi) • Stivarga (regorafenib)
6d
Inavolisib-based Combination Therapy for the Treatment of PIK3CAMutated HR+/HER2- Breast Cancer: An Overview. (PubMed, Mini Rev Med Chem)
Furthermore, it discusses the emerging resistance mechanisms to PI3K inhibition, mitigation of adverse effects, and future directions for inavolisib in personalized oncology. As studies continue to demonstrate its clinical utility, inavolisib exhibits preferential activity against the mutated PI3Kα isoform, thereby enhancing therapeutic specificity for combination therapy.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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HER-2 negative • PIK3CA mutation
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Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
8d
Targeting FGFR signaling overcomes therapeutic resistance and immune evasion in oncogenic PIK3CA-driven serous-like endometrial cancer. (PubMed, bioRxiv)
FGFR inhibition reversed these changes and synergized with anti-PD-1 therapy to enhance antitumor immune responses and establish durable immune memory. Collectively, these findings identify FGFR signaling as a key driver of therapeutic resistance and immune escape in SEC and support FGFR-targeted combination strategies.
Journal • PD(L)-1 Biomarker • IO biomarker
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1)
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TP53 mutation • PIK3CA mutation
8d
Analytical and clinical validation of a novel CE-IVD kit for PIK3CA hotspot mutations in liquid biopsy samples. (PubMed, J Liq Biopsy)
Concordance with both commercially available assays was high, with minor discrepancies attributable to differences in mutation coverage or detection thresholds. In conclusion, the CE-IVD Oncolipsy PIK3CA kit represents a highly detectability, specific and cost-effective real-time PCR-based solution for high throughput detection of four clinically relevant PIK3CA hotspot mutations in liquid biopsy samples.
Journal • Liquid biopsy • BRCA Biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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HER-2 positive • PIK3CA mutation • BRCA mutation
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cobas® PIK3CA Mutation Test
8d
Genomic Landscape and Therapeutic Implications of Metaplastic Breast Carcinoma: Insights from a Nationwide Database Including Diagnostic Mimickers. (PubMed, Pharmaceuticals (Basel))
While the therapeutic associations are based on a limited cohort and require prospective validation, the integration of comprehensive genomic and single-cell profiling provides an exploratory framework that may potentially enhance diagnostic accuracy in the future. However, these associations remain preliminary and require prospective validation to confirm their clinical utility.
Journal
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TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • HRAS (Harvey rat sarcoma viral oncogene homolog)
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PIK3CA mutation • HRAS mutation