In short
Clinical trials are investigating Inavolisib in several cancer types, mainly breast cancer, but also solid tumors, endometrial cancer, ovarian tumors, and prostate cancer. These studies look at safety, effectiveness, and how well Inavolisib works in different treatment combinations. Most trials are in people with biomarker-selected cancers, such as PIK3CA-mutated disease.
Key points
- Clinical trials of Inavolisib are mainly studying breast cancer, especially biomarker-selected disease such as PIK3CA-mutated, hormone receptor-positive, and HER2-negative or HER2-positive cancer. The trial set also includes advanced solid tumors, rare ovarian tumors, endometrial cancer, and metastatic castration-resistant prostate cancer. Most studies are Phase 2 or Phase 3, with one Phase 1 study in metastatic breast cancer. The main goals are to see whether Inavolisib helps tumors shrink, delays cancer getting worse, and improves response after surgery or during maintenance treatment. Many trials test Inavolisib in combination with other cancer medicines and compare it with placebo or another active treatment. Safety, lab changes, and treatment tolerability are also important parts of the research.
Clinical trial overview
The trial data show that Inavolisib is being studied in several cancer research programs, with the strongest focus on breast cancer. The studies include people with early-stage, locally advanced, metastatic, and treatment-resistant disease, and many are designed around specific biomarkers such as PIK3CA mutation.
Most of the listed studies are interventional trials, which means researchers assign a treatment plan and then measure what happens. The trial phases include Phase 1, Phase 2, and Phase 3, showing that Inavolisib is being tested in both early research and larger comparison studies.
Breast cancer studies
Several trials study Inavolisib in breast cancer, including early breast cancer, locally advanced disease, metastatic disease, and maintenance treatment after first-line therapy. Some studies focus on HR-positive disease, which means the cancer grows in response to hormones, while others focus on HER2-positive or HER2-negative disease.
In NCT05306041, researchers are comparing endocrine therapy plus trastuzumab and pertuzumab with or without Inavolisib in patients with HER2-positive, HR-positive, PIK3CA-mutant early breast cancer. The main goal is to compare pathological complete response, which means no microscopic invasive cancer is found in tissue removed at surgery.
In 2023-505812-39-00, Inavolisib is being tested with palbociclib and fulvestrant in people with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer. This Phase 3 study compares the Inavolisib combination with placebo plus the same partner drugs, and the main endpoint is progression-free survival, meaning the time before the cancer gets worse or the patient dies.
In 2024-516162-11-00, researchers are testing Inavolisib with a CDK4/6 inhibitor and letrozole against placebo with the same backbone treatment in advanced breast cancer. The study measures time to disease progression or death, using standard scan-based criteria called RECIST v1.1.
Another Phase 3 study, 2022-502322-41-00, compares Inavolisib plus fulvestrant with alpelisib plus fulvestrant in HR-positive, HER2-negative, PIK3CA-mutated metastatic breast cancer after progression on CDK4/6 inhibitor and endocrine therapy. Its primary endpoint is blinded independent central review-assessed progression-free survival, which means outside experts review the scans without knowing which treatment the patient received.
In 2022-502046-28-00, Inavolisib is being studied as maintenance therapy with Phesgo after first-line induction treatment in untreated HER2-positive, PIK3CA-mutated locally advanced or metastatic breast cancer. The main outcome is investigator-assessed progression-free survival.
The early breast cancer research also includes 2024-518811-20-00, which looks at safety and tolerability of Inavolisib-based combinations in early-stage PIK3CA-mutated breast cancer. Safety is measured using adverse events, laboratory results, treatment exposure, dose changes, and treatment stopping because of side effects.
In 2025-522805-39-00, Inavolisib is being compared at two doses with fulvestrant in PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer. The study looks at confirmed objective response rate and also tracks key side effects such as hyperglycemia, stomatitis or oral mucositis, and diarrhea.
In 2025-523013-28-00, researchers are testing Inavolisib plus ribociclib and fulvestrant against placebo plus the same partner drugs in endocrine-resistant HR-positive, HER2-negative advanced breast cancer with chromosome 8p loss and without a PIK3CA mutation. The main endpoint is investigator-assessed confirmed objective response rate.
The large Phase 1 MORPHEUS-panBC study, 2023-503629-20-00, includes several metastatic breast cancer types such as triple negative, HR-positive, HER2-positive, and HER2-low disease. In this study, Inavolisib is part of a platform of multiple treatment combinations, and the early outcomes include response rate and safety measures such as adverse events, vital signs, ECG findings, and lab tests.
Other cancer studies
Inavolisib is also being studied outside breast cancer, showing that researchers are testing it in a broader cancer setting. The TAPISTRY platform study, 2023-507418-28-00, includes advanced or metastatic solid tumors with biomarker-positive or alteration-positive disease. Its main endpoint is independent review committee-assessed objective response rate using RECIST v1.1.
The BOUQUET study, 2023-508194-89-00, looks at persistent or recurrent rare epithelial ovarian tumors and uses biomarker-driven treatment choices. Inavolisib is one of the study drugs, and the main endpoint is confirmed objective response rate as judged by the investigator.
In 2025-522981-61-00, Inavolisib is being tested in advanced endometrial cancer with PIK3CA mutations. The trial aims to measure activity by objective response rate over the whole treatment period.
The prostate cancer study, 2025-521327-67-00, evaluates Inavolisib plus enzalutamide versus the investigator's choice of enzalutamide, abiraterone, or docetaxel in metastatic castration-resistant prostate cancer. The main endpoint is radiographic progression-free survival, which means time before scans show the cancer has grown.
Trial phases and endpoints
The trial phases help show how far along the research is. Phase 1 studies are usually early studies that focus on safety and initial activity, while Phase 2 and Phase 3 studies are larger and often compare treatments more directly.
Common endpoints across these studies include objective response rate, progression-free survival, radiographic progression-free survival, pathological complete response, and ctDNA change.
Some studies also measure safety in detail, including adverse events, laboratory changes, vital signs, ECG results, dose modifications, and treatment discontinuation because of side effects.
The ctDNA-based study, 2023-505661-89-00, is different because it measures the proportion of patients who have at least a 90% drop or complete clearance of baseline ctDNA three months after starting treatment. This is a way to track tumor DNA in the blood and see whether treatment is working very early.
Who can join these studies
People can join only if they meet the rules for a specific trial. These rules often include cancer type, stage of disease, and biomarker status, such as PIK3CA mutation, HR-positive status, HER2 status, or chromosome 8p loss.
Some studies are for untreated patients, some are for people whose cancer has come back or spread, and some are for patients whose cancer has already progressed after other treatments.
The rollover study, 2023-504263-16-00, is different because it is an extension study for people who were already in a Genentech and/or F. Hoffmann-La Roche sponsored study and still need continued access to treatment. Its main purpose is to provide continued treatment when local access is not available.
Treatment combinations being tested
Inavolisib is mainly being studied as part of combination treatment rather than alone. The partner drugs include fulvestrant, letrozole, palbociclib, ribociclib, trastuzumab, pertuzumab, enzalutamide, and other cancer medicines depending on the trial.
Some studies compare Inavolisib combinations with placebo, which is a look-alike treatment that does not contain the active study drug.
Across the trials, the main research question is whether Inavolisib can improve cancer control, response, or disease-free time in selected patient groups while still being acceptable in terms of safety and tolerability.