The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Women aged 18 - 75 years old;
Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
Patients with histologically confirmed locally advanced or metastatic breast cancer;
Patients with prior adjuvant endocrine resistance following curative-intent surgery;
Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
Patients with a history of clinically significant cardiovascular disease;
Parallel
HRS-8080 Tablet ; Dalpiciclib Isethionate
Drug* HRS-8080 Tablet * Dalpiciclib Isethionate
Fulvestrant injection ;Dalpiciclib Isethionate
Drug* Fulvestrant injection * Dalpiciclib Isethionate
Investigator assessed Progression free survival (PFS)
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.
Progression free survival (PFS) evaluated by the blinded independent central review (BICR)
Overall response rate (ORR)
Clinical benefit rate (CBR)
Duration of response (DOR)
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