CTIS2022-502980-39-00招募中1 期
A Phase III, Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared with Fulvestrant, both Combined with a CDK4/6 Inhibitor, in Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer with Resistance to Prior Adjuvant Endocrine Therapy - CO44657
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,050
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •2. Confirmed ESR1 mutation status in baseline ctDNA, 3. Resistance to prior standard adjuvant ET, defined as relapse on-treatment after = 12 months or off-treatment within 12 months of completion. If adjuvant ET included a CDK4/6i, relapse should have occurred = 12 months since completion of CDK4/6i treatment, 4. Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease, 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, 1. Locally advanced or metastatic adenocarcinoma of the breast not amenable to treatment with curative intent, with documented ER+ HER2- status assessed locally based on the most recent tumor biopsy (or archived tumor sample)
排除标准
- •2. Prior treatment with a SERD (e.g., fulvestrant, investigational), 3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications, 4. Active cardiac disease or history of cardiac dysfunction, 5. Clinically significant history of liver disease, 1. Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
研究者
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