16 recruiting, 7 active not recruiting, 7 not yet recruiting, 3 completed. 23 Phase 2, 9 Phase 1, 5 Phase 3.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes Inavolisib, Fulvestrant, Palbociclib - Breast Cancer, Diabetes Type II Phase 2 Recruiting 40 2026-10-30 2026-10-20 Oral GDC-0077 in Premature Ovarian Insufficiency GDC-0077 - Primary Ovarian Insufficiency Phase 1 Not yet recruiting 12 2026-10-30 2026-10-29 A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients Inavolisib - Pancreatic Ductal Adenocarcinoma (PDAC) Phase 2 Not yet recruiting 62 2026-08-29 2026-07-10 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. Inavolisib + Ribociclib + Fulvestrant - Breast Cancer Phase 2 Not yet recruiting 160 2026-06-01 2026-06-01 A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i - Breast Cancer Not yet recruiting 100 2026-05-16 2026-04-21 Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4 Inavolisib - Endometrial Cancer Phase 2 Not yet recruiting 48 2026-05-01 2026-04-13 A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Inavolisib, Ribociclib, Fulvestrant - Breast Cancer Phase 2 Recruiting 80 2026-04-07 2026-11-03 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 Inavolisib in Combination With Eribulin - TNBC - Triple-Negative Breast Cancer, TNBC Phase 2 Not yet recruiting 26 2026-03-15 2026-03-02 A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer Inavolisib, Enzalutamide, Abiraterone - Metastatic Castration-Resistant Prostate Cancer Phase 2 Recruiting 100 2026-03-11 2026-11-06 To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer Inavolisib, Fulvestrant - Breast Cancer Phase 2 Recruiting 80 2026-02-18 2026-11-03 A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer Inavolisib, Bevacizumab, FOLFOX - Colorectal Cancer Phase 2 Withdrawn 2026-02-01 2026-02-09 A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Inavolisib, Palbociclib, Fulvestrant - Locally Advanced Breast Cancer, Metastatic Breast Cancer Recruiting 500 2026-01-21 2026-11-05 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 fixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib. - Breast Cancer Phase 2 Not yet recruiting 164 2025-12-15 2025-11-24 A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Inavolisib, Ribociclib, Letrozole - Breast Cancer Phase 2 Recruiting 120 2025-09-09 2026-10-26 A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib Inavolisib - Hepatic Impairment Phase 1 Completed 27 2025-08-21 2026-10-23 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 Inavolisib, Placebo, CDK4/6i - Breast Cancer Phase 3 Recruiting 450 2025-04-09 2026-11-04 A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population Giredestrant, Abemaciclib, Inavolisib - Breast Cancer Phase 2 Active not recruiting 976 2024-04-01 2026-09-24 A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers Inavolisib, Atezolizumab - PIK3CA-Mutated Cancers Phase 1 Active not recruiting 30 2023-12-11 2026-08-20 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 Inavolisib, Phesgo, Placebo - Metastatic Breast Cancer Phase 3 Recruiting 230 2023-09-08 2026-10-16 Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Atezolizumab 1200 mg in 20 ML Injection, Inavolisib, Ipatasertib - Early-stage Breast Cancer Phase 2 Recruiting 240 2023-06-29 2025-03-20
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Conditions studied Breast Neoplasms (17) · Colorectal Neoplasms (3) · Neoplasm Metastasis (3) · Endometrial Neoplasms (2) · Triple Negative Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (1) · Diabetes Mellitus, Type 2 (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Neoplasm, Residual (1) · Neoplasms (1) · Ovarian Neoplasms (1) · Primary Ovarian Insufficiency (1)
Sponsors Hoffmann-La Roche (18) · Genentech, Inc. (4) · German Cancer Research Center (2) · Alliance Foundation Trials, LLC. (1) · Bryan Schneider, MD (1) · Fudan University (1) · GBG Forschungs GmbH (1) · Hu Hai (1) · MedSIR (1) · National Cancer Institute, Naples (1) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (1) · Women's Hospital School Of Medicine Zhejiang University (1) · Zhimin Shao (1) · xuliang (1)
Countries United States (21) · Spain (17) · South Korea (15) · United Kingdom (15) · Canada (14) · Germany (14) · Australia (12) · Italy (12) · France (11) · Poland (10) · Brazil (9) · China (8) · Taiwan (8) · Argentina (7) · Belgium (7)
Top investigators Andreas Schneeweiss, Prof. Dr. (1) · Anna Passarelli (1) · Antonio Llombart, MD (1) · Bryan P Schneider, MD (1) · Mattea Reinisch, PD Dr. med. (1) · Richard Schlenk, Prof. Dr. (1) · Xianjun YV (1)
Results publications PMID 39476340 , PMID 40454641 , PMID 34808524 , PMID 37611121 , PMID 38052910 , PMID 39236276 , PMID 40022843 , PMID 40086048 , PMID 40632992 , PMID 40896848 , PMID 41213248 , PMID 41280894 , PMID 41392942 , PMID 42701058
NIH funding 2023 (9) , 2025 (5) , 2016 (1) , 2017 (1) , 2019 (1)