Prediction of Everolimus-induced Interstitial Lung Disease in Breast Cancer Patients; Maximizing Efficacy by Reducing Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- predictive factors of everolimus-induced ILD
研究概览
简要总结
The investigators will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.
详细描述
In this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. The investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ILD). The investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ILD.
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
- •Adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- •Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
- •Postmenopausal women
- •Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment
- •Resistance to treatment with a non-steroidal aromatase inhibitor
- •Serum platelets ≥ 100x10E9/l
- •Everolimus dose adjustment is recommended for patients with hepatic impairment (Child-Pugh A/B/C)
- •Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
排除标准
- •Patients with a HER2-overexpressing tumor
- •Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
- •Patients with a known history of HIV seropositivity or hepatitis B or C
- •Uncontrolled diabetes mellitus
- •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- •Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
结局指标
主要结局
predictive factors of everolimus-induced ILD
时间窗: six months
Find the correlation between: * pneumoproteins * everolimus exposure * pulmonary function tests * four distinct radiological patterns of 1.0mm CT slices of the lungs * baseline patient characteristics * the development and grade of everolimus-induced skin toxicity and oral mucositis and the development and grade of everolimus-induced ILD
次要结局
- temporal relation pneumoproteins and ILD(six months)
- pathophysiology of everolimus-induced ILD(six months)
- relation ILD and exposure and outcome(six months)