Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Pathological response rate
研究概览
简要总结
Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:
- Complete pathological response rate to definitive breast surgery;
- Rate of thromboembolic events.
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
- •Patients with normal organ functions
- •Cytologically/histologically proven breast cancer, stage IIB-IIIC
- •Participants must not have prophylactic or therapeutic indications for anticoagulants.
排除标准
- •Metastatic breast cancer
- •Previous chemotherapy, hormone therapy, radiotherapy
- •Previous malignancies or contralateral breast cancer
结局指标
主要结局
Pathological response rate
时间窗: 30 months
The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.
次要结局
未报告次要终点