CTIS2023-505871-63-00招募中1 期
A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK4/6 INHIBITOR THERAPY (OPERA-01) - OP-1250-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 864
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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 will be allowed. • 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 (LHRH) agonist.
排除标准
- •Symptomatic visceral disease, imminent organ failure, or any disease burden that makes the participant ineligible for endocrine therapy. • Have received prior chemotherapy (including an antibody-drug conjugate) in the advanced/metastatic setting. • 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, or gastrointestinal disorders that could aff+F120ect absorption of study treatment, and others
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