RANDOMIZED CLINICAL TRIAL TO COMPARE THE BENEFIT OF ADDING HERCEPTIN TO CAPECITABINE PLUS VINORELBINE AS SECOND LINE TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED NON OPERABLE OR METASTATIC BREAST CANCER WITH OVEREXPRESSION OF HER-2, WHO HAVE PROGRESSED TO A PREVIOUS LINE OF TREATMENT FOR METASTATIC DISEASE WITH TRASTUZUMAB IN COMBINATION WITH TAXANES

GRUPO ESPAÑOL DE INVETIGACION EN CANCER DE MAMA (GEICAM)0 个研究点目标入组 82 人开始时间: 2006年5月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients must sign an informed consent before of specific procedures of clinical trial.
•Patients with histologically confirmed breast cancer and overexpression of HER2.
•Age > 18 years.
•Patients with locally advanced non operable or mestatatic breast cancer previously treated with a regimen of chemotherapy that included trastuzumab and taxanes.
•Clinical measurable or not measurable disease defined by the RECIST criteria.
•Women of childbearing potential must have a negative pregnancy test (serum or
•urine beta HCG) within 14 days prior to initiation of chemotherapy.
•Patients should have adequate organ function to tolerate chemotherapy.
•ECOG equal or < 2.
•Inclusion of male patients is allowed.
•Are the trial subjects under 18?
•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)
•F.1.3.1 Number of subjects for this age range

•Patients with hypersensitivity reactions to any of the medications of the clinical trial.
•Patients who are pregnant or lactating are not eligible.
•Active infection or a concomitant serious disease

发起方

GRUPO ESPAÑOL DE INVETIGACION EN CANCER DE MAMA (GEICAM)