This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer.
Women aged 18 years or older who are postmenopausal or premenopausal/perimenopausal, and meet one of the following criteria: previous bilateral oophorectomy, or age ≥60 years; or age <60 years with natural menopause (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), and estradiol (E2) and follicle-stimulating hormone (FSH) levels in the postmenopausal range; or premenopausal or perimenopausal women willing to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy during the study period.
Patients with histologically confirmed HR+/HER2- breast cancer (based on the most recent test results from either recurrent/metastatic lesion tissue samples or prior primary lesion tissue samples): a) ER+ and/or PR+ is defined as ≥10% of tumor cells showing positive staining for ER/PR; b) HER2- is defined as an immunohistochemistry(IHC) score of 0 or 1+, or a fluorescence in situ hybridization(FISH) ratio of HER2/CEP17 less than 2.0, or HER2 gene copy number less than 4.
Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.
Previous endocrine therapy must meet one of the following criteria: a) progression during or within 12 months after discontinuation of adjuvant endocrine therapy (with an aromatase inhibitor [aromatase inhibitor or selective estrogen receptor modulator such as tamoxifen, toremifene, etc.); b) progression during or within 1 month after discontinuation of endocrine therapy for first recurrence or metastasis.
The patient has provided written informed consent and is willing and able to comply with the planned visits, study treatment schedule, laboratory tests, and other study procedures.
Patients who are deemed by the investigator to be unsuitable for endocrine therapy, including those with symptomatic, visceral metastatic disease, or those at risk of life-threatening complications in the short term (including patients with uncontrollable effusions [pleural, pericardial, peritoneal] despite drainage or other measures, pulmonary lymphangitis, or more than 50% liver involvement).
Known uncontrolled or symptomatic active central nervous system (CNS) metastases, characterized by clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth; patients with a history of CNS metastases or spinal cord compression may be eligible if they have received definitive treatment and have been clinically stable for 4 weeks after discontinuation of anticonvulsants and corticosteroids prior to the first dose of study drug.
Previous treatment with fulvestrant, everolimus, or CDK4/6 inhibitors.
Parallel
BEBT-209 capsules
DrugOral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
BEBT-209 Placebo capluses
DrugOral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
Fulvestrant Injection
Drug500 mg intramuscular injection, with a 28-day treatment cycle. Administration on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle.
PFS assessed by the Independent Imaging Review Committee
Progression free survival (PFS) assessed by the Independent Imaging Review Committee
PFS assessed by investigators
Progression free survival assessed by investigators
OS
Overall Survival
ORR
Overall Objective Response
CBR
Clinical Benefit Rate
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BeBetter Med Inc
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
