10 recruiting, 5 not yet recruiting, 4 active not recruiting, 2 completed. 23 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 23 | Recruiting 10, Not yet recruiting 5, Active not recruiting 4, Completed 2, Terminated 1, Withdrawn 1 |
| Phase 1 | 3 | Recruiting 3 |
| Phase 3 | 1 | Active not recruiting 1 |
Follow inavolisib: new trials by email Literature Review of inavolisib trials Research Report on inavolisib
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 | Hoffmann-La Roche | 40 | 2026-11-30 | 2026-11-13 |
| 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 | Fudan University | 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 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 160 | 2026-06-01 | 2026-06-01 |
| Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4 Inavolisib - Endometrial Cancer | Phase 2 | Not yet recruiting | National Cancer Institute, Naples | 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 | Hoffmann-La Roche | 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 | Hu Hai | 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 | Hoffmann-La Roche | 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 | Hoffmann-La Roche | 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 | Hoffmann-La Roche | 2026-02-01 | 2026-02-09 | |
| 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 | Zhimin Shao | 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 | Hoffmann-La Roche | 120 | 2025-09-09 | 2026-10-26 |
| 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 | MedSIR | 976 | 2024-04-01 | 2026-09-24 |
| 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 | German Cancer Research Center | 240 | 2023-06-29 | 2025-03-20 |
| Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer Inavolisib, PHESGO, Endocrine therapy - HER2-positive Breast Cancer | Phase 2 | Recruiting | GBG Forschungs GmbH | 170 | 2023-01-02 | 2026-09-11 |
| A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer Atezolizumab - 28 Day Cycle, Bevacizumab, Ipatasertib - Endometrial Cancer | Phase 1 / Phase 2 | Recruiting | Alliance Foundation Trials, LLC. | 148 | 2021-10-20 | 2026-04-01 |
| CRAFT: The NCT-PMO-1602 Phase II Trial Vemurafenib, Cobimetinib, Atezolizumab - Metastatic or Locally Advanced Malignancies | Phase 2 | Completed | German Cancer Research Center | 72 | 2021-10-13 | 2025-01-08 |
| A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Ipatasertib, Cobimetinib, Trastuzumab Emtansine - Ovarian Cancer | Phase 2 | Active not recruiting | Hoffmann-La Roche | 176 | 2021-10-07 | 2026-09-10 |
| Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer Capecitabine, Talazoparib, Pembrolizumab - Breast Cancer, Triple Negative Breast Cancer | Phase 2 | Terminated | Bryan Schneider, MD | 52 | 2021-08-24 | 2025-05-31 |
| A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer Giredestrant, Abemaciclib, Ipatasertib - Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | Hoffmann-La Roche | 316 | 2021-06-22 | 2026-11-03 |
| Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Entrectinib, Alectinib, Atezolizumab - Solid Tumors | Phase 2 | Active not recruiting | Hoffmann-La Roche | 920 | 2021-01-18 | 2026-09-04 |
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Breast Neoplasms (11) · Endometrial Neoplasms (2) · Neoplasm Metastasis (2) · Triple Negative Breast Neoplasms (2) · Colorectal Neoplasms (1) · Diabetes Mellitus, Type 2 (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Neoplasm, Residual (1) · Ovarian Neoplasms (1)
Hoffmann-La Roche (11) · German Cancer Research Center (2) · Alliance Foundation Trials, LLC. (1) · Bryan Schneider, MD (1) · Fudan University (1) · GBG Forschungs GmbH (1) · Genentech, Inc. (1) · Hu Hai (1) · MedSIR (1) · National Cancer Institute, Naples (1) · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (1) · Zhimin Shao (1)
United States (13) · Spain (11) · Germany (10) · South Korea (8) · United Kingdom (8) · Australia (7) · Italy (7) · Canada (6) · France (6) · Brazil (5) · Argentina (4) · Poland (4) · Turkey (Türkiye) (4) · Belgium (3) · China (3)
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)
PMID 34808524, PMID 39476340, PMID 40022843, PMID 40086048, PMID 40454641, PMID 40896848, PMID 41213248, PMID 41392942, PMID 42701058
2023 (5), 2025 (5), 2017 (1), 2019 (1)