This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
Women aged 18 to 75 years old (including both values).
ECOG Physical Strength Status (PS) : 0 to 1 point.
Patients with locally advanced or metastatic breast cancer confirmed by histology.
Patients previously received 1-2 lines of endocrine therapy.
Patients previously received other systemic anti-tumor treatments besides chemotherapy、endocrine therapy and CDK4/6i (prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations).
Nitrosorea or mitomycin was received within 6 weeks before the first study administration in this study; Have undergone major organ surgery, cytotoxic drugs, immunotherapy, , anti-tumor traditional or Chinese medicine medications within 4 weeks before the first study administration and within 4 weeks or 5 half lives (whichever is shorter) prior to the first study drug administration ; Have received endocrine therapy (referring to aromatase inhibitors [AI], etc.) and palliative radiotherapy within 2 weeks before the first study administration.
the date from the first study administration to the last CYP3A4 strong inducer administration is less than 28 days.
Patients with rapid disease progression and investigators determines that endocrine therapy is not suitable or tolerant.
Parallel
HRS-8080 Tablet
DrugHRS-8080 tablet orally administered.
Fulvestrant injection
DrugFulvestrant injection.
Exemestane tablets
DrugExemestane tablets orally administered.
Everolimus Tablets
DrugEverolimus tablets orally administered.
Anastrozole Tablets
DrugAnastrozole tablets orally administered.
Letrozole Tablets
DrugLetrozole tablets orally administered.
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
Progression free survival (PFS) evaluated by investigators.
Overall response rate (ORR).
Clinical benefit rate (CBR).
Duration of response (DOR).
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