NCT06544577招募中不适用
Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+/HER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study
SciClone Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年7月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Adverse event rate
研究概览
简要总结
This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
- •female ≥ 18 years of age
- •female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old < age ≤ 60 years old with 1 year of menopause. d) Age <60 years and receiving ovarian suppression therapy.
- •ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
- •must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
- •have normal organ function (as assessed by the investigator).
排除标准
- •women who are pregnant or breastfeeding
- •known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
- •other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
研究组 & 干预措施
ELacestrant
Subjects in this cohort will receive elacestrant
干预措施: ELacestrant (Drug)
结局指标
主要结局
Adverse event rate
时间窗: 6 months
Percentage of occurrences of adverse events
次要结局
- Serious adverse event rate(6 months)
研究者
研究点 (1)
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