^
    1d
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=976, Recruiting, MedSIR | Trial completion date: Dec 2028 --> Jun 2028 | Trial primary completion date: Dec 2028 --> Jun 2028
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint®
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    2d
    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
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Aliqopa (copanlisib)
    2d
    EAY131-Z1G: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    Aliqopa (copanlisib)
    2d
    EAY131-Z1H: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    PTEN mutation
    |
    Aliqopa (copanlisib)
    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
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability)
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    4d
    Targeting Semaphorin 7a signaling in preclinical models of endocrine therapy-resistant breast cancer. (PubMed, Mol Cancer Ther)
    Using mouse models of ER+BC (FVB/N mice, TC11 tumor model), we show reduced growth of SEMA7A+ tumors with PI3K inhibitors (GCT-007:10 mg/kg daily, alpelisib: 20mg/kg daily), alone or in combination with tamoxifen (0.5mg/100uL, every 3rd day). Combination of an anti-SEMA7A antibody (SmAbH1) (100-250 ug/100uL, every other day) and fulvestrant (83 mg/kg, every 5 days) also revealed that direct inhibition of SEMA7A via SmAbH1 significantly reduces tumor growth of SEMA7A-expressing tumors, and that the efficacy of SmAbH1 is not diminished by the standard of care, fulvestrant. Overall, our studies suggest that patients with ER+SEMA7A+ tumors should be candidates for PI3K-targeted therapies or anti-SEMA7A-based therapy.
    Preclinical • Journal
    |
    ER (Estrogen receptor) • SEMA7A (Semaphorin 7A)
    |
    ER positive
    |
    tamoxifen • Piqray (alpelisib) • fulvestrant
    4d
    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 (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Hu Hai
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • HER-2 negative + HR negative
    |
    Halaven (eribulin mesylate) • Itovebi (inavolisib)
    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
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    12d
    optINAVO: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Itovebi (inavolisib)
    16d
    MedOPP485: A proof of concept study to evaluate treatmentsefficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer population (2023-505661-89-00`2022-002616-24)
    P1/2, N=1071, Recruiting, Medica Scientia Innovation Research S.L.
    New P1/2 trial • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    therascreen® PIK3CA RGQ PCR Kit
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    17d
    VVD-159642-01: A PHASE 1/1B, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF VVD-159642 AS A SINGLE AGENT AND IN COMBINATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS (2025-522148-42-00)
    P1, N=32, Not yet recruiting, Vividion Therapeutics Inc.
    New P1 trial • First-in-human
    17d
    CBYL719F12202: EPIK-P4: A Phase II single-arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS) (2024-519960-42-00)
    P1/2, N=72, Recruiting, Novartis Pharma AG
    New P1/2 trial
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Piqray (alpelisib)