Molecular profiling of postmenopausal women with breast cancer on neoadjuvant exemestane or tamoxifen - MoNET

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 26 人开始时间: 2006年5月3日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Women with histological diagnosis of primary invasive breast cancer on core biopsy
•- Not a candidate for chemotherapy
•- Localised or locally advanced breast cancer
•- Ultrasound size at least 10mm
•- No previous treatment for breast cancer
•- ER positive (allred score >4)
•- Palpable and measureable disease in the breast or axilla
•- Post menopausal defined by the following criteria: cessation of menstrual periods for at least 1 year or bilateral surgical oophorectomy or follicular stimulating hormone (FSH) and oestradiol in the post-menopausal range
•- At least 2 weeks since prior hormone replacement therapy or phyto-oestrogens herbal, alternative, or over-the counter (OTC) sex hormone remedies and not on concomitant hormonal therapy with these agents
•- ECOG performance status 0,1or 2
•- Randomisation and treatment within 4 weeks of biopsy
•- Patient must have adequate bone marrow, hepatic and renal function
•- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•- Written consent for the trial
•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 2
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•- Patient unfit to receive endocrine-based therapy
•- Previous history of cancer excluding basal cell carcinoma, cervical carcinoma in-situ, or ductal carcinoma in situ of the breast
•- Previous deep vein thrombosis or pulmonary embolism

发起方