Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Overall Survival
研究概览
简要总结
Experimental, clinical, and epidemiological studies have all demonstrated the strong association between chronic inflammation and cancer, and many studies have correlated the prolonged presence of the inflammatory milieu with an increased risk for developing cancer.(1) Although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2, hormones, or PI3 kinase. (2).
In actual clinical practice there exist clear guidelines for the use of aspirin in colorectal cancer but no such guidelines exist for the use of aspirin in breast cancer patients.
In the Unit´s proper experience, in patients under active surveillance and metastatic ones some present very good responses both in the neoadjuvant and in the metastatic setting but investigators intend to provide evidence and not just the experience. This study patients are proposed to combine their standard treatment with aspirin.
详细描述
Breast cancer patients with diagnosis of Ductal or Lobular Invasive Carcinoma or CDis that refuse to underwent surgery or are not qualified for, and independently of age or of their actual staging, are going to be allocated, randomly and in double masked way to one of two arms:
Arm 1: standard Unit´s protocol + placebo Arm 2: standard Unit´s protocol + aspirin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Every adult (above 18) y.o.patient with histologic diagnosis of Breast Cancer that refuse or is not suitable for surgical treatment, or with metastatic disease, remaining this way in an "active surveillance"
排除标准
- •Allergy or toxicity to aspirin
研究组 & 干预措施
1
Arm 1: standard Unit´s protocol + placebo
干预措施: Placebo Oral Tablet (Drug)
B
Arm 2: standard Unit´s protocol + aspirin
干预措施: Aspirin Low Dose (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 years
Patients Overall survival in arm 2 superior to the arm 1
次要结局
- Tumor response till patient decides to exit the active surveillance(6 months)
- Metastatic Disease Stability(1 year)
研究者
Zacharoula Sidiropoulou
Principal Investigator
Centro Hospitalar Lisboa Ocidental
