NCT07076680撤回不适用
Safety and Effectiveness in Patients With HR+/HER2- Advanced Breast Cancer: a Prospective, Noninterventional Real-world Study
SciClone Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The goal of this observational study is to learn about the safety and effectiveness of people with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-).
Participants will:
Allow researchers to collect medical data during routine care
Be followed for signs of treatment effectiveness and any medical problems that happen while taking the drug
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
- All
- 接受健康志愿者
- 否
入选标准
- •1. must have a histologically or cytologically confirmed diagnosis of breast cancer and evidence of locally advanced or metastatic disease that is not amenable to surgical resection.
- •2. Women or men ≥ 18 years of age.
- •must be confirmed as HR+ and HER2- by local laboratory tests. Confirmation of this status can be done by a first visit tissue sample or a post-treatment sample (recent biopsy sample preferred if available).
- •4. Testing to confirm ESR1 mutation positivity should be performed on tumor DNA taken from tissue samples or circulating tumor DNA (ctDNA) obtained from plasma samples using a well-validated assay. Accept the results of the central laboratory or local laboratory tests, and in the event of inconsistency between the two test results, the investigator determines whether enrollment is possible.
- •5. previous treatment with at least one endocrine therapy, either as monotherapy or in combination with another drug, at an advanced stage.
- •6. have a life expectancy greater than 3 months and normal organ function (as assessed by the investigator).
排除标准
- •Pregnant or lactating females.
- •Known difficulty tolerating oral medications, or the presence of conditions that would interfere with the absorption of oral medications or allergies to medications and their excipients.
- •3. Other conditions that the investigator considers inappropriate for enrollment.
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: From first dose until 30 days after last dose or end of follow-up (approximately 6 to 12 months)
The number and percentage of participants who experience any adverse event (AE) during treatment, regardless of severity or causality. Events will be coded using standard terminology (e.g., MedDRA).
次要结局
- Incidence of Serious Adverse Events (SAEs)(From first dose until 30 days after last dose or end of follow-up)
- Rate of Dose Modifications Due to Adverse Events(From Day 1 (first dose) through the end of treatment (up to 24 months))
- Rate of Discontinuation Due to Adverse Events(From Day 1 (first dose) through the end of treatment (up to 24 months))
研究者
研究点 (1)
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