OncoMatch/Clinical Trials/NCT07368998
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Is NCT07368998 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Inavolisib and Fulvestrant for breast cancer.
Treatment: Inavolisib · Fulvestrant — The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA study-eligible mutation
Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
Prior therapy
Must have received: CDK4/6 inhibitor — locally advanced or metastatic
Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy
Must have received: endocrine therapy — locally advanced or metastatic
Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy
Cannot have received: chemotherapy
Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
Cannot have received: PI3K inhibitor
Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
Cannot have received: Akt inhibitor
Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
Cannot have received: mTOR inhibitor
Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Los Angeles Cancer Network · Los Angeles, California
- Astera Cancer Care East Brunswick · East Brunswick, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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