ISRCTN58579496已完成3 期

First prospective Intergroup Translational Research Trial assessing the potential predictive value of p53 using a functional assay in yeast in patients with locally advanced/inflammatory or large operable breast cancer prospectively randomised to a taxane versus a non taxane regimen

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)0 个研究点目标入组 1,850 人开始时间: 2010年5月19日最近更新: 2018年11月12日

研究概览

暂无简介。

•1. Histologically confirmed breast cancer: Locally advanced or inflammatory disease:
•1.1. + T4a-d, any N, M0, or
•1.2. + Any T, N2 or N3, M0
•1.3. + Large T2 or T3 breast cancer requiring tumor shrinkage prior to breast conservation surgery
•2. Frozen tumor sample available:
•2.1. One incisional biopsy, or
•2.2. Two trucut biopsies from a 14G needle
•3. No prior chemotherapy
•4. No prior radiotherapy
•5. Age: 70 and under
•7. Performance status: World Health Organization (WHO) 0 - 1
•8. Neutrophil count greater than 1,500/mm^3
•9. Platelet count greater than 100,000/mm^3
•10. Bilirubin less than 1.2 mg/dL
•11. Serum glutamic oxaloacetic transaminase (SGOT) less than 60 IU/L
•12. Creatinine less than 1.35 mg/dL
•13. Left ventricular ejection fraction (LVEF) normal by echocardiography or multiple gated acquisition scan (MUGA)

•1. No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
•2. No serious uncontrolled medical condition
•3. No uncontrolled psychiatric or addictive disorders
•4. Not pregnant or nursing
•5. Fertile patients must use effective contraception

发起方

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)