EUCTR2014-000808-10-SE进行中（未招募）1 期
PREDIX HER2 - Neoadjuvant response-guided treatment of HER2 positive breast cancer. Part of a platform of translational phase II trials based on molecular subtypes - PREDIX HER2
Karolinska University Hospital0 个研究点目标入组 200 人开始时间: 2014年8月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent
- •2.Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker
- •3.Tumor and blood samples available. HER2 type confirmed by genomic profiling using Next-Generation Sequencing.
- •4.Age 18 years or older. Elderly patients in condition adequate for planned therapy
- •5.Primary breast cancer >20mm in diameter and/or verified lymph node metastases
- •6.Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
- •7.LVEF >55%
- •8.ECOG performance status 0-1
- •9.Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
- •2.Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- •3.Patients in child-bearing age without adequate contraception
- •4. Pregnancy or lactation
- •4.Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
研究者
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