A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

Inclusion Criteria

• •1. Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
• •2. Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
• •3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
• •4. Have disease that has demonstrated progression on or after prior treatment:
• •1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
• •2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
• •5. Eastern Cooperative Oncology Group Performance Status 0-1
• •6. Adequate organ function