EUCTR2009-010786-22-IT进行中（未招募）不适用
Open label, phase III, multicentric randomised trial, comparing five years of treatment with a non steroidal aromatase inhibitor, either anastrozole or letrozole, versus switching after 2-3 years to the steroidal aromatase inhibitor exemestane in early stage breast cancer patients. - DOUBLE
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO0 个研究点开始时间: 2009年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1) Women with histologically proven invasive breast cancer completely removed
- •by surgery, any pT, any pN
- •2) Postmenopausal status defined by at least one of the following conditions:
- •Age > 60 years
- •. Age between 45 and 59 years satisfying one or more of the following criteria:
- •a)amenorrhea for > 12 months and intact uterus; b)amenorrhea for < 12 months
- •and prior hysterectomy or prior chemotherapy with a FSH level of 50 IU/l or
- •more; c)prior bilateral oophorectomy
- •3) Positive ER and/or PgR (according to local cut-off)
- •4) Adjuvant/neoadjuvant chemotherapy, if given, must be completed before
- •5) Patients with HER-2 positive tumors are eligible provided that they have
- •received trastuzumab according to registered scheduled
- •6) Signed informed consent.
- •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
排除标准
- •1) Concurrent HRT
- •2) Clinical evidence of recurrent or metastatic disease (M1) at randomization
- •3) Previous history of invasive breast cancer or other malignancy whitin the
- •previous 10 years, other than squamous or basal cell carcinoma of the skin or
- •carcinoma in situ of the cervix
- •4) Concomitant severe disease and/or any condition which can contraindicate
- •continuing with an aromatase inhibitor or that might jeopardize patient
- •participation
- •5) Treatment with other experimental drugs.
研究者
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