NCT05293470招募中不适用
A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 20
- 主要终点
- Incidence of AEs
研究概览
简要总结
This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting
详细描述
The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for this study must meet all of the following criteria:
- •Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer.
- •Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label.
- •Patients who are willing to provide written informed consent
排除标准
- •Subjects eligible for this study must not meet the following criteria:
- •Patients with contraindication according to prescribing information for Piqray in Korea.
- •- Severe hypersensitivity to Piqray or to any of its components
- •Female subjects who are pregnant and nursing (lactating)
- •Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
- •Participants who receive or are going to receive any investigational medicine during surveillance period.
结局指标
主要结局
Incidence of AEs
时间窗: 24 weeks
Incidence of AEs, including SAEs and ADRs
次要结局
- Prescription dose of Piqray in combination with fulvestrant(Up to 24 weeks)
- Objective response rates (ORRs)(Up to 24 weeks)
研究者
研究点 (20)
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