A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
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 received no more than one line of chemotherapy in the recurrence/metastasis stage.
• Menstrual status (meeting any of the following conditions) : a) After bilateral ovariectomy; b) Age ≥60 years old; c) Age \< 60 years old, natural menopause ≥12 months, without receiving chemotherapy, tamoxifen (TAM), tolemiphene or ovarian castration in the past year, follicle-stimulating hormone (FSH) and estradiol are within the postmenopausal range; d) For patients under the age of 60 who are taking TAM or tolemiphene, the levels of FSH and estradiol are within the postmenopausal range; e) Premenopausal or perimenopausal patients received luteinizing hormone-releasing hormone (LHRH) agonist treatment during the study period, and the treatment was initiated at least 14 days before the start of the study.
• Patients comply with any of the following provisions of the RECIST v1.1 standard: a) There is at least one extracranial measurable lesion; b) If there are no measurable lesions as stipulated above, at least one osteolytic or mixed (osteolytic and osteogenic) bone lesion that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) exists.
• Expected survival \> 6 months.
• The functional level of the organs must meet the requirements.
⁃ Female with fertility must agree to use effective contraceptive measures for contraception during the study treatment period and within 7 months after the end of the study treatment period; Femalewith fertility must have a negative serum human chorionic gonadotropin (hCG) test within 7 days before enrollment in the study and must be in the non-lactation period.
⁃ Voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.