Gene Variant Detail

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03337724	Phase II	Ipatasertib + Paclitaxel Paclitaxel	A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)	Completed	USA \| TUR \| SVN \| POL \| ITA \| HUN \| GRC \| GBR \| FRA \| ESP \| DEU \| CZE \| CAN \| BRA \| BEL \| AUS \| ARG	13
NCT02728258	Phase II	Copanlisib	Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer	Completed	USA	0
NCT04495621	Phase Ib/II	Cetuximab + MEN1611	MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)	Completed	USA \| POL \| NLD \| ITA \| FRA \| ESP \| DEU	0
NCT01708161	Phase I	Alpelisib + Ganitumab	A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors	Terminated	USA \| ESP \| CAN \| BEL	0
NCT01776008	Phase II	Goserelin + MK2206	Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer	Terminated	USA	0
NCT05646862	Phase III	Alpelisib + Fulvestrant Fulvestrant + Inavolisib	A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121)	Recruiting	USA \| TUR \| POL \| ITA \| GBR \| FRA \| ESP \| DEU \| CAN \| BRA \| BEL \| AUS \| ARG	6
NCT05216432	Phase I	RLY-2608 Fulvestrant + RLY-2608	First-in-Human Study of Mutant-selective PI3Kalpha Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer	Recruiting	USA \| ITA \| FRA \| ESP \| AUS	0
NCT02124148	Phase I	Cisplatin + Prexasertib Cetuximab + Prexasertib Pemetrexed Disodium + Prexasertib LY3023414 + Prexasertib Fluorouracil + Leucovorin + Prexasertib	A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer	Completed	USA	0
NCT03065062	Phase I	Gedatolisib + Palbociclib	Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors	Recruiting	USA	0
NCT04191499	Phase II	Fulvestrant + Palbociclib Fulvestrant + Inavolisib + Palbociclib	A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120)	Active, not recruiting	USA \| TUR \| POL \| NZL \| ITA \| HUN \| GRC \| GBR \| FRA \| ESP \| DNK \| DEU \| CAN \| BRA \| BEL \| AUS \| ARG	11
NCT05563220	Phase Ib/II	Alpelisib + Elacestrant Elacestrant + Ribociclib Elacestrant + Everolimus Elacestrant + Palbociclib Abemaciclib + Elacestrant	Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)	Recruiting	USA \| TUR \| POL \| LUX \| ITA \| ISR \| HUN \| GBR \| FRA \| ESP \| DEU \| CZE \| BRA \| BEL \| AUS \| ARG	1
NCT04774952	Phase I	RMC-5552	Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors	Active, not recruiting	USA	0
NCT01791478	Phase I	Alpelisib + Letrozole	BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer	Active, not recruiting	USA	0
NCT02189174	Phase Ib/II	CLR457	Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies	Terminated	USA \| ESP \| CAN	2
NCT01219699	Phase I	Alpelisib Alpelisib + Fulvestrant	A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene	Completed	USA \| NLD \| GBR \| ESP \| DEU	0
NCT03056755	Phase II	Alpelisib + Fulvestrant Alpelisib + Letrozole	Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve)	Active, not recruiting	USA \| NLD \| ITA \| ISR \| GBR \| FRA \| ESP \| DNK \| DEU \| CAN \| BEL \| ARG	7
NCT05683418	Phase I	TOS-358	A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors	Recruiting	USA	0
NCT00770263	Phase I	Erlotinib + Temsirolimus	Erlotinib and Temsirolimus for Solid Tumors	Completed	USA	0
NCT06680596	Phase II	Trastuzumab deruxtecan	Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy (SAFIR3LibHERty)	Not yet recruiting	FRA	0
NCT02644122	Phase II	SF1126	SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes	Terminated	USA	0
NCT01306045	Phase II	Erlotinib Lapatinib MK2206 Sunitinib Selumetinib	Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies	Completed	USA	0
NCT04208178	Phase III	Pertuzumab + Trastuzumab Alpelisib + Pertuzumab + Trastuzumab	Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (EPIK-B2)	Active, not recruiting	USA \| ITA \| FRA \| ESP \| BEL	2
NCT05768139	Phase Ib/II	Fulvestrant + STX-478 STX-478	First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors	Recruiting	USA \| ITA \| FRA \| ESP	0
NCT03767335	Phase I	Fulvestrant + MEN1611 + Trastuzumab MEN1611 + Trastuzumab	MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01)	Completed	USA \| ITA \| GBR \| FRA \| ESP \| BEL	0
NCT04762979	Phase II	Alpelisib + Fulvestrant	Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer	Recruiting	USA	0
NCT06496568	Phase I	Atezolizumab + Inavolisib Inavolisib	A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers	Recruiting	USA \| CAN	1
NCT02315625	Phase II	Everolimus Sunitinib	Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery	Terminated	USA	0
NCT04300790	Phase II	Alpelisib + Fulvestrant + Metformin	Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients (METALLICA)	Active, not recruiting	ESP	0
NCT05933395	Phase II	Abemaciclib + Fulvestrant Fulvestrant + Neratinib Alpelisib + Fulvestrant Everolimus + Fulvestrant	Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE)	Recruiting	USA	0
NCT05356897	Phase II	Trastuzumab + Trifluridine-tipiracil hydrochloride + Tucatinib	Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study	Withdrawn	USA	0
NCT05708235	Phase II	Giredestrant + Inavolisib Abemaciclib + Giredestrant Giredestrant	A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR)	Active, not recruiting	GBR \| ESP	0
NCT02576444	Phase II	Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib	OLAParib COmbinations (OLAPCO)	Terminated	USA	0
NCT04916236	Phase I	LY3214996 + RMC-4630	Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers (SHERPA)	Unknown status	NLD	0
NCT04251533	Phase III	Alpelisib + Nab-paclitaxel Nab-paclitaxel	Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3)	Active, not recruiting	USA \| TUR \| SVN \| SVK \| POL \| NOR \| ITA \| ISR \| HUN \| HRV \| GBR \| FRA \| ESP \| DEU \| CHE \| BRA \| BGR \| AUT \| AUS \| ARG	10
NCT01226316	Phase I	Capivasertib	Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules	Active, not recruiting	USA \| NLD \| ITA \| GBR \| FRA \| ESP \| DNK \| CAN	2
NCT03218826	Phase I	AZD8186 + Docetaxel	PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery	Active, not recruiting	USA	0
NCT04997902	Phase Ib/II	Alpelisib + Tipifarnib	Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)	Recruiting	USA	0
NCT04192981	Phase I	GDC-0084	GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases	Active, not recruiting	USA	0
NCT04253561	Phase I	Ipatasertib + Pertuzumab + Trastuzumab	Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (IPATHER)	Recruiting	ESP	0
NCT03006172	Phase I	Inavolisib + Letrozole + Palbociclib Inavolisib Fulvestrant + Inavolisib Inavolisib + Letrozole	To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer	Active, not recruiting	USA \| GBR \| FRA \| ESP \| CAN	0
NCT02987959	Phase II	Sapanisertib	Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas	Terminated	USA	0
NCT02646319	Phase I	Nab-rapamycin	Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations	Completed	USA	0
NCT02167854	Phase I	Alpelisib + Elgemtumab + Trastuzumab	Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer	Completed	USA	0
NCT05063786	Phase III	Alpelisib + Fulvestrant + Trastuzumab Trastuzumab + Vinorelbine Alpelisib + Trastuzumab Capecitabine + Trastuzumab Eribulin + Trastuzumab	Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (ALPHABET)	Active, not recruiting	NLD \| ITA \| FRA \| ESP \| CHE \| AUT	0
NCT02523014	Phase II	Abemaciclib GSK2256098 Vismodegib Capivasertib	Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas	Recruiting	USA	0
NCT02861300	Phase Ib/II	Capecitabine + Telaglenastat	CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer	Active, not recruiting	USA	0
NCT04958226	Phase I	Capivasertib + Midazolam	A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours	Completed	USA	0
NCT04899349	Phase II	Alpelisib + Fulvestrant + Metformin Alpelisib + Dapagliflozin + Fulvestrant + Metformin	Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (EPIK-B4)	Terminated	USA	1
NCT05810870	Phase II	Eribulin + MEN1611 MEN1611	PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA)	Recruiting	ESP	0
NCT02340221	Phase III	Fulvestrant + Taselisib Fulvestrant	A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER)	Terminated	USA \| TUR \| SWE \| ROU \| POL \| NLD \| ITA \| GRC \| FRA \| FIN \| ESP \| DEU \| CZE \| CAN \| BGR \| AUT \| AUS	11
NCT05894239	Phase III	Inavolisib + Pertuzumab/trastuzumab/hyaluronidase-zzxf Pertuzumab/trastuzumab/hyaluronidase-zzxf	A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer	Recruiting	USA \| TUR \| POL \| ITA \| GBR \| FRA \| FIN \| ESP \| DEU \| CAN \| BRA \| BEL \| AUS \| ARG	11
NCT03155620	Phase II	Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib	Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)	Recruiting	USA \| CAN \| AUS	1
NCT05304962	Phase I	RGT-419B	FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer	Recruiting	USA	0
NCT01470209	Phase I	Buparlisib + Everolimus	A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies	Completed	USA	0
NCT03834740	Phase I	Everolimus + Ribociclib	A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection	Completed	USA	0
NCT01971515	Phase I	M2698	First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies	Completed	USA	0
NCT03297606	Phase II	Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib	Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR)	Recruiting	CAN	0
NCT01928459	Phase I	Alpelisib + Infigratinib	Phase 1b Trial of BGJ398/BYL719 in Solid Tumors	Completed	USA \| NLD \| ITA \| FRA \| ESP \| DEU \| CHE \| CAN \| BEL \| AUS	2
NCT01396408	Phase II	Temsirolimus Sunitinib	A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours	Active, not recruiting	CAN	0
NCT03032406	Phase II	Everolimus + Hydroxychloroquine Everolimus Hydroxychloroquine	CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer	Active, not recruiting	USA	0
NCT05773326	Phase I	Temsirolimus	Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG	Recruiting	USA	0
NCT01437566	Phase II	Apitolisib Fulvestrant Pictilisib	Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy	Completed	USA \| NZL \| ITA \| ISR \| GBR \| FRA \| ESP \| DNK \| DEU \| CAN \| BEL \| AUS \| ARG	10
NCT02961283	Phase I	ASN003	Study of ASN003 in Subjects With Advanced Solid Tumors	Terminated	USA	0
NCT05038735	Phase III	Alpelisib + Fulvestrant Fulvestrant	Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5)	Recruiting	SVK \| ROU \| POL \| ITA \| IRL \| HUN \| GRC \| FRA \| FIN \| ESP \| DNK \| DEU \| CZE \| CAN \| BGR \| BEL	1
NCT06287463	Phase Ib/II	DCC-3084	Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway	Recruiting	USA	0

Gene	PIK3CA
Variant	mutant
Impact List	unknown
Protein Effect	unknown
Gene Variant Descriptions	PIK3CA mutant indicates an unspecified mutation within the PIK3CA gene.
Associated Drug Resistance
Category Variants Paths

Gene Variant Detail

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