PIK3CA activating mutation

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

25 of 43 drugs shown

Show all 43 drugs

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

1. Roche 8
2. Novartis 5
3. Eli Lilly 2
4. Relay Therapeutics 2
5. Stemline Therapeutics 2
6. AstraZeneca 1
7. Chengdu JOYO pharma 1
8. Laekna 1
9. Risen (Suzhou) Pharma Tech 1
10. Aminex Therapeutics 1
11. Criterium 1
12. Ensem Therapeutics 1
13. KymaThera 1
14. Pikavation Therapeutics 1
15. Recursion Pharmaceuticals 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention PIK3CA activating mutation rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

60 of 138 trials shown

1. JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer

   Not yet recruiting Phase 3 Chengdu JOYO pharma Started 2026Primary completion 2028-11 NCT07784036

   fulvestrant FDA EU

   JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer

   Breast Cancer

2. A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

   Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT07174336

   STX-478ribociclibpalbociclib FDA EUabemaciclibanastrozoleletrozoleExemestanefulvestrant FDA EU

   Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.

   Breast Neoplasms, Neoplasm Metastasis

3. A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

   Recruiting Phase 3 Risen (Suzhou) Pharma Tech Started 2025Primary completion 2029-05 NCT07207070

   JS105Dalpiciclibfulvestrant FDA EU

   Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;

   Breast Cancer

4. Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

   Recruiting Phase 3 Relay Therapeutics Started 2025Primary completion 2028-04 NCT06982521

   Zovegalisibcapivasertib FDA EUfulvestrant FDA EU

   One or more known primary oncogenic PIK3CA mutation(s)

   PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer

5. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

   Recruiting Phase 3 Roche Started 2025Primary completion 2032-01 NCT06790693

   inavolisib FDA EUCDK4/6iletrozole

   …and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

   Breast Cancer

6. Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

   Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-10 NCT06635447

   capivasertib FDA EUfulvestrant FDA EU

   Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients en…

   Breast Cancer

7. 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 Phase 3 Roche Started 2023Primary completion 2026-12 NCT05894239

   inavolisib FDA EUPhesgoTaxane-based ChemotherapyOptional Endocrine Therapy of Investigator's Choice

   Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documen…

   Metastatic Breast Cancer

8. Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

   Recruiting Phase 2/3 Novartis Started 2023Primary completion 2028-05 NCT05948943

   alpelisib FDA EU

   Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

   Lymphatic Malformations

9. 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

   Recruiting Phase 3 Roche Started 2023Primary completion 2026-11 NCT05646862

   inavolisib FDA EUfulvestrant FDA EUalpelisib FDA EUBupropionOmeprazolemidazolam

   …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 Ther…

   Breast Cancer

10. Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer

    Active, not recruiting Phase 3 Laekna Started 2022Primary completion 2026-10 NCT04851613

    afuresertibfulvestrant FDA EU

    Only patients with PIK3CA/AKT1/PTEN alterations could include.

    Breast Cancer

11. Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

    Active, not recruiting Phase 3 Novartis Started 2021Primary completion 2027-01 NCT05038735

    alpelisib FDA EUfulvestrant FDA EU

    The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laborat…

    Breast Cancer

12. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

    Active, not recruiting Phase 2/3 Roche Started 2020Primary completion 2023-09 NCT04191499

    inavolisib FDA EUpalbociclib FDA EUfulvestrant FDA EU

    …b + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

    Breast Cancer

13. 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

    Active, not recruiting Phase 3 Novartis Started 2020Primary completion 2027-02 NCT04208178

    alpelisib FDA EUtrastuzumabpertuzumab

    Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or…

    Advanced HER2+Breast Cancer

14. Adjuvant Low Dose Aspirin in Colorectal Cancer

    Active, not recruiting Phase 3 Anna Martling Started 2016Primary completion 2024-08 NCT02647099

    aspirin

    Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN

    Colorectal Cancer

15. Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

    Recruiting Phase 1/2 Aminex Therapeutics Started 2026Primary completion 2028-02 NCT07287917

    AMXT 1501 DicaprateDFMOfulvestrant FDA EUcapivasertib FDA EUpembrolizumab

    …cancer patients: locally advanced or metastatic breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations following progression on at least 2 endocrine-based regimens in the metastatic setting or…

    Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer

16. Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4

    Not yet recruiting Phase 2 National Cancer Institute, Naples Started 2026Primary completion 2030-05 NCT07522697

    inavolisib FDA EU

    Biomarker eligibility: valid results from testing of tumor tissue documenting PIK3CA mutations listed below (a-m)

    Endometrial Cancer

17. REC-7735 in Participants With Solid Tumors

    Recruiting Phase 1/2 Recursion Pharmaceuticals Started 2026Primary completion 2031-01 NCT07819136

    REC-7735

    …ly-confirmed unresectable, locally advanced, or metastatic solid tumors which exhibit the PIK3CA H1047R mutation in tumor tissue and/or blood (circulating tumor deoxyribonucleic acid \[ctDNA\])…

    Solid Tumors

18. A Phase 1/2a Study of K-1728 in Advanced Solid Tumors

    Not yet recruiting Phase 1/2 KymaThera Started 2026Primary completion 2028-09 NCT07861932

    K-1728fulvestrant FDA EUpalbociclib FDA EU

    Documented activating PIK3CA mutation

    Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation

19. Rash & Diarrhea Prophylaxis With Capivasertib

    Recruiting Phase 2 Maryam Lustberg Started 2026Primary completion 2027-04 NCT07426822

    capivasertib FDA EULoperamidefulvestrant FDA EUCeterizine

    Participants with metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as confirmed by local or central testing of tumor tissue and/or circulating tumor DNA (c…

    Metastatic HR+/HER2- Breast Cancer

20. A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

    Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2026Primary completion 2028-12 NCT07618390

    inavolisib FDA EUribociclibfulvestrant FDA EU

    …fficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

    Breast Cancer

21. A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation

    Not yet recruiting Phase 2 Hu Hai Started 2026Primary completion 2028-03 NCT07441512

    inavolisib FDA EUeribulin

    …results from central testing of tumor tissue documenting the presence of a study-eligible PIK3CA mutation.

    TNBC - Triple-Negative Breast Cancer, TNBC

22. To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

    Recruiting Phase 2 Roche Started 2026Primary completion 2028-10 NCT07368998

    inavolisib FDA EUfulvestrant FDA EU

    Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation

    Breast Cancer

23. Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

    Not yet recruiting Phase 1/2 Shanxi Province Cancer Hospital Started 2026Primary completion 2028-10 NCT07486648

    capivasertib FDA EUosimertinib

    Mandatory provision of the required number of FFPE tumour tissue samples for PIK3CA mutations and/or AKT1 mutations and/or PTEN loss-of-function (LOF) mutations testing, which fulfils…

    Lung Cancer (NSCLC), Lung Cancer (Non-Small Cell), Advanced Non-small-cell Lung Cancer

24. Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Ensem Therapeutics Started 2025Primary completion 2027-06 NCT06993844

    ETX-636 dose escalationfulvestrant FDA EU

    Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.

    Advanced Solid Tumors, Advanced Breast Cancer

25. SNV4818 in Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Pikavation Therapeutics Started 2025Primary completion 2027-04 NCT06736704

    SNV4818fulvestrant FDA EUpalbociclib FDA EU

    Advanced or metastatic solid tumor with an activating PIK3CA mutation.

    Advanced Solid Tumors

26. A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

    Recruiting Phase 2 Roche Started 2025Primary completion 2027-07 NCT07054190

    inavolisib FDA EUribociclibletrozolegiredestrant

    Confirmed PIK3CA mutation

    Breast Cancer

27. A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC

    Not yet recruiting Phase 2 Zhimin Shao Started 2025Primary completion 2026-12 NCT07245797

    pertuzumabtrastuzumabnab-paclitaxelinavolisib FDA EU

    HER2+ disease with confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value on core biopsy (target lesion).

    Breast Cancer

28. A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

    Active, not recruiting Phase 2 GOG Foundation Started 2024Primary completion 2028-05 NCT05154487

    alpelisib FDA EUfulvestrant FDA EU

    …based on hysterectomy or biopsy specimen and have positive expression of ER and oncogenic PIK3CA mutation per criteria below.

    Endometroid Endometrial Cancer

29. Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

    Recruiting Phase 2 GBG Forschungs Started 2023Primary completion 2027-01 NCT05306041

    inavolisib FDA EUPHESGOEndocrine therapy

    HR+/HER2+ disease with centrally confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value and TILs on core biopsy (target lesion).

    HER2-positive Breast Cancer

30. Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2023Primary completion 2026-07 NCT05983107

    everolimusChidamideEndocrine therapyOvarian function suppression(OFS)

    PIK3CA Mutant subjects were enrolled in queue A

    Status may be outdated, last updated 2023-08-09HR+/HER2- Advanced Breast Cancer, Targeted Therapy

31. PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin

    Active, not recruiting Phase 2 MedSIR Started 2023Primary completion 2026-04 NCT05810870

    MEN1611eribulin

    Patient has a PIK3CA mutation confirmed by MEDSIR's designated central lab, determined in the pre-screening phase or pa…

    Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer

32. Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

    Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

    elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

    Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

    Breast Cancer, Metastatic Breast Cancer

33. Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

    Active, not recruiting Phase 1/2 Criterium Started 2022Primary completion 2026-03 NCT05230810

    alpelisib FDA EUtucatinibfulvestrant FDA EU

    Documented presence of activating mutation in PIK3CA in the tumor, based on the analysis of solid or liquid biopsy by an assay approved for cl…

    HER2-positive Metastatic Breast Cancer

34. Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

    Recruiting Phase 1/2 SynDevRx Started 2022Primary completion 2026-12 NCT05455619

    Evexomostat

    Patient has identified PI3K pathway alteration, defined as a PIK3CA mutation or PTEN loss or an AKT1 mutation using a Food and Drug Administration (FDA)-approved test…

    HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer

35. SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

    Active, not recruiting Phase 2 Borstkanker Onderzoek Groep Started 2022Primary completion 2026-05 NCT05392608

    alpelisib FDA EUfulvestrant FDA EU

    The presence of an activating PIK3CA mutation

    Neoplasm, Breast, Congenital, Familial and Genetic Disorders

36. Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2021Primary completion 2027-10 NCT05090358

    alpelisib FDA EUfulvestrant FDA EUCanagliflozin

    Presence of one or more activating PIK3CA mutations in tumor tissue.

    Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer

37. Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer

    Active, not recruiting Phase 2 Novartis Started 2021Primary completion 2027-01 NCT04544189

    alpelisib FDA EUfulvestrant FDA EU

    Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)

    Breast Neoplasms

38. Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

    Active, not recruiting Phase 2 Marina N Sharifi Started 2021Primary completion 2025-10 NCT04762979

    alpelisib FDA EUfulvestrant FDA EUAromatase inhibitor

    PIK3CA mutation identified via local testing from tumor tissue or blood.

    Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, PIK3CA Mutant Metastatic Breast Cancer

39. Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

    Active, not recruiting Phase 2 Novartis Started 2021Primary completion 2027-02 NCT04524000

    alpelisib FDA EUfulvestrant FDA EU

    Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)

    Advanced Breast Cancer

40. A Trial of Ipatasertib in Combination With Atezolizumab

    Active, not recruiting Phase 1/2 Institute of Cancer Research, United Kingdom Started 2018Primary completion 2026-03 NCT03673787

    ipatasertibatezolizumab

    …other aberrations predicted to result in a hyperactivated PI3K-AKT pathway (eg activating mutations in PIK3CA, AKT1, AKT2) or PTEN loss (assessed by immunohistochemistry (IHC) (n=12).

    Solid Tumor, Glioblastoma Multiforme, Prostate Cancer Metastatic

41. Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2021-01 NCT05490771

    copanlisib

    Patients must have PIK3CA mutation as determined via the MATCH Master Protocol

    Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Refractory Lymphoma

42. Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2016Primary completion 2020-11 NCT04439175

    taselisib

    Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol

    Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

43. Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2015Primary completion 2028-06 NCT02523014

    VismodegibFAK Inhibitor GSK2256098capivasertib FDA EUabemaciclib

    For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= …

    Intracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation

44. PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

    Active, not recruiting Phase 2 Washington University School of Medicine Started 2013Primary completion 2021-04 NCT01723774

    palbociclib FDA EUanastrozoleGoserelin

    Pre-registration PIK3CA Mutant Inclusion

    Breast Neoplasms

45. A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Cogent Biosciences Started 2026Primary completion 2029-07 NCT07383506

    CGT6297

    Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor:

    PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer

46. A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

    Not yet recruiting Phase 1 Pfizer Started 2026Primary completion 2030-03 NCT07897721

    PF-08165784fulvestrant FDA EUAtirmociclibcetuximabletrozole

    Phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) mutation

    Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma

47. Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

    Recruiting Phase 1 Regor Pharmaceuticals Started 2026Primary completion 2028-04 NCT07524322

    RGT-490

    Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.

    Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation

48. GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.

    Recruiting Phase 1 Changchun GeneScience Pharmaceutical Started 2026Primary completion 2028-11 NCT07407504

    GenSci145 tablets

    Central or local test results are required to confirm the presence of eligible PIK3CA mutations in tumor tissue or blood samples.

    Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated

49. A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma

    Recruiting Phase 1 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025Primary completion 2028-01 NCT07306299

    Glioma-related multi-target mRNA vaccines

    …rboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.

    Glioma, High Grade

50. A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

    Recruiting Phase 1 Stemline Therapeutics Started 2024Primary completion 2027-10 NCT06638307

    MEN2312elacestrant

    Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.

    Advanced Breast Cancer

51. Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

    Recruiting Phase 1 BridgeBio Oncology Therapeutics Started 2024Primary completion 2028-11 NCT06625775

    BBO-10203trastuzumabfulvestrant FDA EUribociclibFOLFOXbevacizumab

    … + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i

    Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors

52. A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

    Recruiting Phase 1 Totus Medicines Started 2023Primary completion 2027-12 NCT05683418

    TOS-358fulvestrant FDA EUpalbociclib FDA EUribociclib

    Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagno…

    HR+/HER2-negative Breast Cancer

53. A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

    Active, not recruiting Phase 1 Roche Started 2023Primary completion 2027-07 NCT06496568

    inavolisib FDA EUatezolizumab

    A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

    PIK3CA-Mutated Cancers

54. A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2022Primary completion 2025-04 NCT05307705

    LOXO-783fulvestrant FDA EUimlunestrantabemaciclibanastrozoleletrozolepaclitaxel

    … H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)

    Breast Cancer

55. First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

    Recruiting Phase 1 Relay Therapeutics Started 2021Primary completion 2027-04 NCT05216432

    RLY-2608fulvestrant FDA EUpalbociclib FDA EUribociclibPF-07220060 100mgPF-07220060 300 mg

    One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment

    PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer

56. Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2019Primary completion 2024-07 NCT03842228

    copanlisibdurvalumabolaparib

    or actionable mutations in the PTEN gene, or hotspot mutations in the PIK3CA gene (E542, E545 or H1047 are accepted).

    Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

57. GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

    Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2019Primary completion 2026-12 NCT04192981

    paxalisib

    Histologically confirmed solid tumor malignancies harboring PIK3CA mutations which include mutations in any of the following genes: PIK3CA, PIK3CB, PIK3CD, PIK3CG, PI…

    Brain Metastases, Leptomeningeal Metastasis

58. 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 Phase 1 Roche Started 2016Primary completion 2026-12 NCT03006172

    inavolisib FDA EUfulvestrant FDA EUletrozolepalbociclib FDA EUmetformintrastuzumabpertuzumab

    Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer

    Breast Cancer, Solid Tumor

59. A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

    Recruiting Early Phase 1 Rambam Health Care Campus Started 2022Primary completion 2026-12 NCT05753657

    Pioglitazone

    Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.

    Status may be outdated, last updated 2023-03-03Metastatic Breast Cancer, Hyperinsulinism, Hyperglycemia Drug Induced

60. HTL0039732 in Participants With Advanced Solid Tumours

    Recruiting Phase 1/2 Cancer Research UK Started 2023Primary completion 2028-12 NCT05944237

    HTL0039732 Capsulesatezolizumab

    MSS CRC with PIK3CA or HER2 mutation/genetic aberration, and/or other driver mutation/genetic aberration as agreed with the Sp…

    Broad match: PIK3CA activating mutationNeoplasms, Prostatic Neoplasms, Castration-Resistant, Stomach Neoplasms, Esophageal Neoplasms

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