PREDIX Luminal A - Neoadjuvant response-guided treatment of slowly proliferating hormone receptor positive tumors. Part of a set of translational phase II trials based on molecular subtypes - PREDIX LumA

Karolinska University Hospital0 个研究点目标入组 200 人开始时间: 2014年9月4日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•1.Written informed consent
•2.Female patients with non-lobular breast cancer confirmed by histology
•3.Tumor and blood samples available. Luminal subtype confirmed by genomic profiling using Next-Generation Sequencing.
•4.Age older than 35 years. Elderly patients in condition adequate for planned therapy
•5. Primary breast cancer >20mm without palpable axillary lymph node metastases. Occult node metastases, detected by either ultrasound of the axilla or sentinel-node biopsy (SNB) performed before start of neoadjuvant treatment can be included
•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.Patients in child-bearing age with adequate contraception
•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 80

•1. Male breast cancer
•2. Lobular cancer
•3. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
•4. 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
•5. Pregnancy or lactation
•6. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.

发起方

Karolinska University Hospital