NCT06392217招募中不适用
Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- the time to first SRE
研究概览
简要总结
This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Male or female aged 18 years or above;
- •Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
- •The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
- •Histologically or cytologically confirmed breast cancer;
- •Imaging or histocytology confirmed bone metastases;
- •There were indications of useing Incadronate and no contraindications in the use of Incadronate;
- •New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease;
- •All women of childbearing age, fertile men or their spouses did not plan to have children or donate sperm throughout the trial period until 6 months after the last dose, or voluntarily took effective contraceptive measures.
排除标准
- •Pregnant or lactating women;
- •Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
- •Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Investigators have identified the primary tumor source of the metastases);
- •Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
- •There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
- •Patients with bleeding tendency;
- •The researcher believes that the patient has other conditions that are not suitable for participating in this study.
结局指标
主要结局
the time to first SRE
时间窗: 12 months
The time from the first treatment with infadronate to the first observation of any SRE
The proportion of patients who had at least one Skeletal-related event（SRE）
时间窗: 12 months
The proportion of patients who had at least one SRE within 12 months after initial treatment with infadronate (including pathological fractures, spinal cord compression, radiotherapy or surgery for bone metastases);
Adverse events
时间窗: 12 months
Incidence and classification of various adverse events of infadronate
次要结局
未报告次要终点
研究者
Jian Zhang,MD
Chief physician
Fudan University
研究点 (1)
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