A phase II, randomized trial with single agent trastuzumab or lapatinib in women with metastatic breast cancer iperexpressing HER2 - ND

AZIENDA OSPEDALIERA ORDINE MAURIZIANO0 个研究点开始时间: 2009年3月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•age between 18 and 75 years; Histologically o citologically confirmed diagnosis of metastatic disease; HER2 iperexpression assessed by FISH; no prior chemotherapy for metastatic or locally recurrent disease; for patients undergoing hormonal treatment for metastatic disease, confirmation of progression is required and performed according to RECIST criteria; increase in the sum of major diameters of at leasrt 20%, or appearance of new metastatic lesions or progression of existing non-target lesions; at least one monodimensionally measurable lesion; patients with involvement of NCS are admitted if: the lesion(s) has/have been radically resected - radiotherapy on the brain lesion(s) has been performed and complete remission can be documented by TC or RMN; at least 4 week`s interval from end of radiotherapy, hormono- or immuno-therapy and enrollment into the protocol; Performance Status (ECOG)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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•prior chemotherapy for metastatic disease; prior treatment with lapatinib; prior therapy with mono- or policlonal antibodies for metastatic disease; bone involvement or pleural effusion/ascites as unique localization of disease; administration of any experimental drug within 4 weeks prior beginning of treatment;

发起方

AZIENDA OSPEDALIERA ORDINE MAURIZIANO