Breast CancerPIK3CA Clinical Trials

23 recruiting trials·Updated daily from ClinicalTrials.gov

PIK3CA activating mutations occur in approximately 40% of HR+/HER2-negative breast cancers and predict benefit from alpelisib, an alpha-specific PI3K inhibitor approved with fulvestrant for metastatic PIK3CA-mutant disease. PIK3CA mutations are associated with endocrine resistance mechanisms. Trials explore next-generation PI3K/AKT/mTOR inhibitors, AKT inhibitor combinations (capivasertib), and biomarker selection strategies.

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Top recruiting PIK3CA Breast Cancer trials

Ranked by phase and US site count.

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Phase 3102 US sites

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

Eli Lilly and Company

Phase 363 US sites

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

Pfizer

Phase 351 US sites

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

Hoffmann-La Roche

Phase 348 US sites

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

Relay Therapeutics, Inc.

Phase 322 US sites

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Celcuity Inc

Phase 320 US sites

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

Hoffmann-La Roche

Additional trials

More PIK3CA Breast Cancer trials

Phase 2

NCT05768139First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid TumorsPhase 1/Phase 229 US sites NCT04802759A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast CancerPhase 1/Phase 211 US sites NCT05455619Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast CancerPhase 1/Phase 210 US sites NCT06993844Phase 1/2 Study of ETX-636 in Participants With Advanced Solid TumorsPhase 1/Phase 210 US sites NCT07287917Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid TumorsPhase 1/Phase 28 US sites NCT07368998To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast CancerPhase 22 US sites NCT07109726A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway AlterationsPhase 1/Phase 214 US sites

Phase 1

NCT05216432First-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 CancerPhase 124 US sites NCT06625775Open-Label Study of BBO-10203 in Subjects With Advanced Solid TumorsPhase 119 US sites NCT06239467First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast CancerPhase 113 US sites NCT05683418A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid TumorsPhase 19 US sites

6 international trials (no US sites)

NCT07281833Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based TreatmentPhase 3 NCT07207070A 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.Phase 3 NCT07054190A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast CancerPhase 2 NCT05708235A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC PopulationPhase 2 NCT05332561Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)Phase 2 NCT05753657A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.Early Phase 1

Other Breast Cancer biomarkers

Browse other molecular targets with active Breast Cancer trials.

HER2 (ERBB2)ESR1 (ER)PGR (PR)BRCA1 BRCA2

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