Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of patients with pathological complete response
研究概览
简要总结
This study compares two approaches of upfront chemotherapy in breast cancer.
详细描述
A Decision Support System (DSS) is an information system that supports business, medical, educational or organisational decision-making activities. DSSs fuse human knowledge and technology to support and improve decision-making.
The area of precision oncology that supports the treatment of breast cancer has not only seen an increase in the availability of different treatment choices but also genomic tools to support the decision-making process. CDSSs have been available for use in clinical oncology practice for over a decade. However, there has been some criticism around the utility of CDSS in personalised medicine decision-making of breast cancer, with these systems often viewed as aids better suited to support the 'average' patient's requirements rather than personalised treatment for the individual patient.
The purpose of the current study is to evaluate an innovative CDSS (MedicBK) platform based on the comparison of multiple treatments simultaneously in making care decisions taking into account the individual characteristics of patients, i.e., based on personalized evidence-based medicine.
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
- None
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
- •Histologically confirmed infiltrating breast cancer
- •Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
- •Eastern Cooperative Oncology Group performance status ≤1
- •Adequate bone marrow function (ANC >1.5 x 109/l, platelets >100 x 109/l)
- •Adequate hepatic function (ALAT, ASAT and bilirubin <2.5 times upper limit of normal)
- •Adequate renal function (creatinine clearance >50 ml/min)
- •LVEF ≥50% measured by echocardiography or MUGA
- •Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Absence of any medical condition that would place the patient at unusual risk.
- •Signed written informed consent
排除标准
- •previous radiation therapy or chemotherapy
- •other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- •current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- •evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
- •evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
- •concurrent anti-cancer treatment or another investigational drug.
研究组 & 干预措施
Neoadjuvant Chemotherapy by CDSS
干预措施: Neoadjuvant Chemotherapy by CDSS (MedicBK) (Device)
Neoadjuvant Chemotherapy in General practice
干预措施: General practice (Drug)
结局指标
主要结局
Number of patients with pathological complete response
时间窗: at week 30
To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS
次要结局
- Number of patients with grade >2 adverse events as a measure of safety and tolerability(up to week 35)
- identify prognostic and predictive for pathological complete response(within one year after end of treatment)
研究者
Evgeny Pokushalov
Director for research and development
Center of Personalized Medicine, Pirogova