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CONTACT
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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
Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
Life expectancy of \> 6 months
Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
You may not be if
Metaplastic breast cancer
Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
Requirement for daily supplemental oxygen
Symptomatic active lung disease, including pneumonitis
Clareo Health | To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
