NCT06938711撤回1 期
A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With Estrogen Receptor-Positive, Progesterone Receptor-Positive, HER2-negative Advanced or Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Characterize the safety of elacestrant in combination with onapristone.
研究概览
简要总结
This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is currently enrolled in the ELONA clinical study (ONA-XR-103) and receiving onapristone or elacestrant, either alone or in combination.
- •Patient is currently benefiting from the treatment in the ELONA clinical study, as determined by the investigator.
- •Patient currently has no evidence of progressive disease, as determined by the investigator.
排除标准
- •Pregnant or nursing (lactating) women.
- •Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
研究组 & 干预措施
Elacestrant / Onapristone
Experimental
Elacestrant and Onapristone combination
干预措施: Elacestrant (Drug)
Elacestrant / Onapristone
Experimental
Elacestrant and Onapristone combination
干预措施: Onapristone (Drug)
结局指标
主要结局
Characterize the safety of elacestrant in combination with onapristone.
时间窗: 7 months
Monitor the treatment-related adverse events as assessed by CTCAE v4.0
次要结局
未报告次要终点
研究者
研究点 (1)
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