A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

Key Inclusion Criteria * Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer * Up to 3 prior lines of therapy for metastatic disease * Willing and able to provide written informed consent for this study * Adults ≥ 18 years old at time of consent * Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test * Measurable or evaluable disease by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Performance status * Life expectancy ≥ 6 months, as determined by the investigator * Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product * Fasting plasma glucose <= 140 mg/dL AND hemoglobin A1c (HbA1c) <= 7.0% * Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test Key Exclusion Criteria * Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2Diabetes * Known active central nervous system (CNS) metastasesBrain metastases * PTEN mutations