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 (Jun 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
Treatments studied
Targeted therapy
Endocrine / hormonal
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 →Frequently asked questions
Is NCT07368998 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, PI3K inhibitor, Akt inhibitor disqualifies patients from enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA study-eligible mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages