Phase II Study of Navelbine oral and Arimidex as neo-adjuvant treatment in post-menopausal women with locally advanced breast carcinoma

Pierre Fabre Medicament represented by IRPF0 个研究点目标入组 62 人开始时间: 2005年1月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Women with a locally advanced measurable (according to RECIST criteria) breast cancer (tumour size >3cm by ultrasound, No-2, M0),
•- Previously untreated with chemotherapy, hormonotherapy, radiotherapy or immunotherapy,
•- Women defined as post-menopausal
•- With WHO performance inferior or equal to 2
•- With adequate haematological, hepatic and renal functions.
•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

•- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorptions of oral vinorelbine
•- Patient with inflammatory breast carcinoma (T4d) or in ipsilateral, infra/supra clavicular lymph nodes (N3)
•- Patient with symptom suggesting brain or leptomeningeal involvment
•- Patient treated with any investigational drug within the 30 days prior to registration
•- Patient with dysphagia (grade superior or equal to 2) or inability to swallow tablets
•- Patient prior to registration, is unwilling to undergo breast surgery at the end of neo-adjuvant treatment
•- Clinically significant cardiovascular, hepatic, neurological or other systemic disease
•- Unwillingness to sto taking any drug affecting sex hormonal status

发起方

Pierre Fabre Medicament represented by IRPF