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临床试验/NCT03491410
NCT03491410Unknown2 期

Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?

Centro Hospitalar Lisboa Ocidental0 个研究点目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Arm 1: standard Unit´s protocol + placebo

干预措施: Placebo Oral Tablet (Drug)

B

Experimental

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

发起方
Centro Hospitalar Lisboa Ocidental
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zacharoula Sidiropoulou

Principal Investigator

Centro Hospitalar Lisboa Ocidental

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