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Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Disease progression after or during treatment with a combination of CDK4\u002F6i and endocrine therapy: \\\u003C= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting\n* Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n* Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines\n* Confirmation of biomarker eligibility: presence of \\>= 1 study-eligible PIK3CA mutation\n* Life expectancy of \\> 6 months\n* Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes\n\nExclusion Criteria:\n\n* Metaplastic breast cancer\n* Prior treatment with chemotherapy in the recurrent locally advanced\u002Fmetastatic setting\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Prior treatment with PI3K\u002FAkt\u002FmTOR inhibitors in the recurrent locally advanced\u002Fmetastatic setting\n* Requirement for daily supplemental oxygen\n* Symptomatic active lung disease, including pneumonitis","ALL","18 Years",{"count":339,"type":340},80,"ESTIMATED","INTERVENTIONAL",[343],"PHASE2","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\u002FmBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.",[346],"Breast 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