这项第三期临床试验比较 palazestrant (OP-1250) 与标准治疗选项 fulvestrant 或芳香酶抑制剂，在曾接受一种激素治疗合并 CDK4/6 抑制剂后疾病进展的乳腺癌女性及男性患者中的安全性与疗效。
适应症：Breast Cancer、Advanced Breast Cancer、Metastatic Breast Cancer、ER Positive Breast Cancer、HER2 Negative Breast Carcinoma
入组条件
纳入标准
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- Evaluable disease (measurable disease or bone-only disease).
- Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal functions.
- Female participants can be pre-, peri- or postmenopausal.
- Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
排除标准
- Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
- Previously received chemotherapy in the advanced/metastatic setting.
- Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
- History of allergic reactions to study treatment.
- Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
- Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
- Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。