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2009年3月3日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- post menopausal women with hormone-receptor positive early stage breast cancer, surgically removed
- 发起方
- IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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.
结局指标
主要结局
未指定
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