TEMOZOLOMIDE IN METASTATIC BREAST CANCER PATIENTS AT HIGH RISK OF BRAIN RECURRENCE: IMPACT ON THE INCIDENCE OF BRAIN METASTASES - STOP

SCHERING-PLOUGH0 个研究点目标入组 158 人开始时间: 2008年7月10日最近更新: 2019年6月30日

试验速览

暂无简介。

•Signed written informed consent Diagnosis of metastatic breast cancer Patients must have completed first line metastatic CHT and have achieved response (CR or PR) or disease stability for at least 6 months No clinical sign of brain progression At least one of the following 3 conditions: o HER2 +++ o Young age (< 50 years) o ER-/PgR- Performance status ECOG ≤ 2 Life expectancy ≥ 3 months Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and haemoglobin ≥ 9 g/dL, lymphocytes ≥ 1 x 109/L Bilirubin level either normal or < 1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis are present) Serum creatine < 1.5 x ULN Effective contraception if the risk of conception exists Age ≥ 18 years
•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

•Concurrent chronic systemic immune therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Patients that have completed 2nd 3rd 4th line metastatic CHT or patients in active chemotherapy treatment Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months Acute or subacute intestinal occlusion or history of inflammatory bowel disease Known grade 3 or 4 allergic reaction to any of the components of the treatment Known drug abuse/alcohol abuse Legal incapacity or limited legal capacity Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Women who are pregnant or breastfeeding Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)

发起方

SCHERING-PLOUGH