A phase II study of primary chemotherapy with pegylated liposomal doxorubicin (Caelyx), Cisplatin, and Fluorouracil (CCF) followed by metronomic Capecitabine, Cyclophosphamide and Sorafenib (CCS) in early and locally advanced, ?triple negative? breast cancer - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2008年7月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-d, N0-3c, M0) or patients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0)
•Patients with triple negative breast cancer (absence of ER, PgR and c-erbB2 expression on tumor cells defined according to EIO guidelines)
•Patients must be suitable for local treatment (surgery) in a multidisciplinary program
•Bilateral breast cancers are eligible
•Women aged >18 years
•Performance status 0-1 (ECOG scale)
•Life expectancy of at least 12 wee
•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

•Presence of tumor expression of ER and PgR
•Presence of tumor HER2/neu overexpression or amplification
•Patients with distant metastatic disease
•Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are the following:

发起方