Table of Contents
- Clinical trial overview
- Breast cancer studies
- Other cancer studies
- Trial phases and endpoints
- Who can join these studies
- Treatment combinations being tested
Clinical trial overview
The trial data show that Inavolisib is being studied in several cancer research programs, with the strongest focus on breast cancer.[1] 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.[1][2]
Most of the listed studies are interventional trials, which means researchers assign a treatment plan and then measure what happens.[1] 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.[1]
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.[1][2] 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.[1][2]
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.[1] The main goal is to compare pathological complete response, which means no microscopic invasive cancer is found in tissue removed at surgery.[1]
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.[3] 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.[3]
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.[4] The study measures time to disease progression or death, using standard scan-based criteria called RECIST v1.1.[4]
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.[5] 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.[5]
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.[6] The main outcome is investigator-assessed progression-free survival.[6]
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.[7] Safety is measured using adverse events, laboratory results, treatment exposure, dose changes, and treatment stopping because of side effects.[7]
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.[8] The study looks at confirmed objective response rate and also tracks key side effects such as hyperglycemia, stomatitis or oral mucositis, and diarrhea.[8]
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.[9] The main endpoint is investigator-assessed confirmed objective response rate.[9]
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.[10] 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.[10]
Other cancer studies
Inavolisib is also being studied outside breast cancer, showing that researchers are testing it in a broader cancer setting.[2] The TAPISTRY platform study, 2023-507418-28-00, includes advanced or metastatic solid tumors with biomarker-positive or alteration-positive disease.[2] Its main endpoint is independent review committee-assessed objective response rate using RECIST v1.1.[2]
The BOUQUET study, 2023-508194-89-00, looks at persistent or recurrent rare epithelial ovarian tumors and uses biomarker-driven treatment choices.[11] Inavolisib is one of the study drugs, and the main endpoint is confirmed objective response rate as judged by the investigator.[11]
In 2025-522981-61-00, Inavolisib is being tested in advanced endometrial cancer with PIK3CA mutations.[12] The trial aims to measure activity by objective response rate over the whole treatment period.[12]
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.[13] The main endpoint is radiographic progression-free survival, which means time before scans show the cancer has grown.[13]
Trial phases and endpoints
The trial phases help show how far along the research is.[1] 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.[10][3]
Common endpoints across these studies include objective response rate, progression-free survival, radiographic progression-free survival, pathological complete response, and ctDNA change.[2][3][1][5][13][7]
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.[7][10]
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.[14] This is a way to track tumor DNA in the blood and see whether treatment is working very early.[14]
Who can join these studies
People can join only if they meet the rules for a specific trial.[1] 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.[3][4][8][9]
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.[6][13][5]
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.[15] Its main purpose is to provide continued treatment when local access is not available.[15]
Treatment combinations being tested
Inavolisib is mainly being studied as part of combination treatment rather than alone.[1][3] The partner drugs include fulvestrant, letrozole, palbociclib, ribociclib, trastuzumab, pertuzumab, enzalutamide, and other cancer medicines depending on the trial.[3][4][6][13]
Some studies compare Inavolisib combinations with placebo, which is a look-alike treatment that does not contain the active study drug.[3][8][9]
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.[1][7][13]
