About this data
Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.
Inavolisib
- Company
- Hoffmann-La Roche
- Mechanism
- Mechanism not yet reported
- Route
- Route not yet reported
- Recruiting trials
- 19 recruiting
Efficacy results: Not yet reported
19 recruiting studies currently listed on ClinicalTrials.gov.
Data source: ClinicalTrials.gov · trial data as of Sep 17, 2026
Find a Clinical Trial Near Me
See recruiting studies for Inavolisib and check eligibility with the study team.
Trial details
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Recruiting NCT NCT03424005
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Not yet reported, Not yet reported Hoffmann-La Roche 1132 participants Est. completion 2030-09-30 53 sites Stand-aloneOther conditions: Metastatic Breast CancerView official trial listing → -
Recruiting NCT NCT04486352
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Not yet reported, Not yet reported Alliance Foundation Trials, LLC. 148 participants Est. completion 2027-10 21 sites Stand-aloneOther conditions: Endometrial CancerView official trial listing → -
Recruiting NCT NCT04802759
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Not yet reported, Not yet reported Hoffmann-La Roche 316 participants Est. completion 2029-05-30 32 sites Stand-aloneOther conditions: Inoperable, Locally Advanced or Metastatic, ER-positive Breast CancerView official trial listing → -
Recruiting NCT NCT04929223
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Not yet reported Hoffmann-La Roche 542 participants Est. completion 2030-08-31 84 sites Stand-aloneOther conditions: Metastatic Colorectal CancerView official trial listing → -
Recruiting NCT NCT05306041
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Not yet reported GBG Forschungs GmbH 170 participants Est. completion 2027-03 62 sites Stand-aloneOther conditions: HER2-positive Breast CancerView official trial listing → -
Recruiting NCT NCT05332561
Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
Not yet reported German Cancer Research Center 240 participants Est. completion 2030-12 9 sites Stand-aloneOther conditions: Early-stage Breast CancerView official trial listing → -
Recruiting NCT NCT05646862
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
Not yet reported Hoffmann-La Roche 420 participants Est. completion 2029-03-30 210 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT05708235
A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
Not yet reported MedSIR 976 participants Est. completion 2028-06-30 41 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT05768139
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Not yet reported, Not yet reported Eli Lilly and Company 880 participants Est. completion 2030-07 65 sitesOther conditions: Breast Cancer, Solid Tumors, AdultView official trial listing → -
Recruiting NCT NCT05862285
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
Not yet reported Hoffmann-La Roche 100 participants Est. completion 2033-03-01 73 sites Stand-aloneOther conditions: CancerView official trial listing → -
Recruiting NCT NCT05894239
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
Not yet reported Hoffmann-La Roche 230 participants Est. completion 2032-12-28 192 sites Stand-aloneOther conditions: Metastatic Breast CancerView official trial listing → -
Recruiting NCT NCT06790693
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
Not yet reported Hoffmann-La Roche 450 participants Est. completion 2032-02-01 241 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT07054190
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
Not yet reported Hoffmann-La Roche 120 participants Est. completion 2027-09-28 34 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT07144111
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Not yet reported Genentech, Inc. 32 participants Est. completion 2026-09-06 4 sites Stand-aloneOther conditions: Hepatic ImpairmentView official trial listing → -
Recruiting NCT NCT07287150
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Not yet reported Hoffmann-La Roche 100 participants Est. completion 2029-07-30 48 sites Stand-aloneOther conditions: Metastatic Castration-Resistant Prostate CancerView official trial listing → -
Recruiting NCT NCT07347600
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
Hoffmann-La Roche 500 participants Est. completion 2029-12-31 30 sitesOther conditions: Locally Advanced Breast Cancer, Metastatic Breast CancerView official trial listing → -
Recruiting NCT NCT07368998
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Not yet reported Hoffmann-La Roche 80 participants Est. completion 2031-10-31 34 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT07405801
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
Not yet reported Hoffmann-La Roche 80 participants Est. completion 2030-02-26 58 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Recruiting NCT NCT07817056
Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence
Tianjin Medical University Cancer Institute and Hospital 100 participants Est. completion 2028-10-31 1 siteOther conditions: Breast Cancer, HyperglycemiaView official trial listing → -
Active, not recruiting NCT NCT03006172
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
Not yet reported Genentech, Inc. 200 participants Est. completion 2026-12-31 12 sites Stand-aloneOther conditions: Breast Cancer, Solid TumorView official trial listing → -
Active, not recruiting NCT NCT04191499
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
Not yet reported, Not yet reported Hoffmann-La Roche 325 participants Est. completion 2027-11-15 135 sites Stand-aloneOther conditions: Breast CancerView official trial listing → -
Active, not recruiting NCT NCT04449874
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Not yet reported Genentech, Inc. 498 participants Est. completion 2027-12-31 63 sites Stand-aloneOther conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid TumorsView official trial listing → -
Completed NCT NCT04551521
CRAFT: The NCT-PMO-1602 Phase II Trial
Not yet reported German Cancer Research Center 72 participants Est. completion 2024-12-30 9 sites Stand-aloneOther conditions: Metastatic or Locally Advanced MalignanciesView official trial listing → -
Active, not recruiting NCT NCT04589845
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Not yet reported Hoffmann-La Roche 920 participants Est. completion 2032-09-25 112 sites Stand-aloneOther conditions: Solid TumorsView official trial listing → -
Completed NCT NCT04632992
A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Not yet reported Genentech, Inc. 252 participants Est. completion 2024-02-27 38 sites Stand-aloneOther conditions: Advanced Unresectable or Metastatic Solid MalignancyView official trial listing → -
Terminated NCT NCT04849364
Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer
Not yet reported Bryan Schneider, MD 52 participants Est. completion 2024-12-02 13 sites Stand-aloneOther conditions: Breast Cancer, Triple Negative Breast CancerView official trial listing → -
Active, not recruiting NCT NCT04931342
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Not yet reported Hoffmann-La Roche 176 participants Est. completion 2028-05-30 41 sites Stand-aloneOther conditions: Ovarian CancerView official trial listing → -
Active, not recruiting NCT NCT06496568
A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
Not yet reported Hoffmann-La Roche 30 participants Est. completion 2027-07-21 5 sites Stand-aloneOther conditions: PIK3CA-Mutated CancersView official trial listing → -
Not yet recruiting NCT NCT07245797
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 reported Zhimin Shao 164 participants Est. completion 2027-02-23 Stand-aloneOther conditions: Breast CancerView official trial listing → -
Withdrawn NCT NCT07323576
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
Not yet reported Hoffmann-La Roche Est. completion 2031-03-31 Stand-aloneOther conditions: Colorectal CancerView official trial listing → -
Not yet recruiting NCT NCT07441512
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 reported Hu Hai 26 participants Est. completion 2028-03-15 Stand-aloneOther conditions: TNBC - Triple-Negative Breast Cancer, TNBCView official trial listing → -
Not yet recruiting NCT NCT07522697
Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4
Not yet reported National Cancer Institute, Naples 48 participants Est. completion 2030-05 1 site Stand-aloneOther conditions: Endometrial CancerView official trial listing → -
Not yet recruiting NCT NCT07543250
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
xuliang 100 participants Est. completion 2027-07-30Other conditions: Breast CancerView official trial listing → -
Not yet recruiting NCT NCT07618390
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 reported Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 160 participants Est. completion 2028-12 Stand-aloneOther conditions: Breast CancerView official trial listing → -
Not yet recruiting NCT NCT07694973
A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients
Not yet reported Fudan University 62 participants Est. completion 2028-07-29 1 site Stand-aloneOther conditions: Pancreatic Ductal Adenocarcinoma (PDAC)View official trial listing → -
Not yet recruiting NCT NCT07748208
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Not yet reported Hoffmann-La Roche 40 participants Est. completion 2029-09-30 Stand-aloneOther conditions: Breast Cancer, Diabetes Type IIView official trial listing →
Efficacy history
Not yet reported.
Safety
Not yet reported.
Sources
Also known as: Inavolisib, Itovebi, RO7113755
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This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.