NCT00908531终止3 期
Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.
Danish Breast Cancer Cooperative Group9 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 9
- 主要终点
- pCR
研究概览
简要总结
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 60 years or older
- •Measurable non-metastatic and non-inflammatory breast cancer
- •Tumor of 2 cm or larger
- •ER and/or PgR positive tumor
- •Co-morbidity index 0 - 3, e.g., no other serious medical condition
排除标准
- •Prior medical therapy for a malignant disease, including aromatase inhibitors
- •Distant metastasis
- •Need for chemotherapy
- •Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
- •Treatment with a non-approved drug within 30 days
研究组 & 干预措施
Postoperative letrozole
Active Comparator
Definitive surgery without preoperative AI treatment
干预措施: letrozole (Femara) (Drug)
Preoperative letrozole
Experimental
Treatment with letrozole for 4 months before definitive surgery.
干预措施: letrozole (Femara) (Drug)
结局指标
主要结局
pCR
时间窗: At four months
Complete response rate
Clinical tumor response
时间窗: At four months
Ultrasound
次要结局
- Overall survival(At ten years)
研究者
Bent Ejlertsen
Professor, MD, PhD
Danish Breast Cancer Cooperative Group
研究点 (9)
Loading locations...
相似试验
招募中
不适用
Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)Embryo TransferIrregular MenstruationLetrozoleHormone Replacement TherapyNCT06372119Mỹ Đức Hospital790
招募中
3 期
Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.Luteinised Follicular CystNCT06244745IVI Madrid152
招募中
3 期
Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial)Carcinoma, Ovarian EpithelialLow Grade Serous Adenocarcinoma of OvaryNCT05601700Ente Ospedaliero Ospedali Galliera132
已完成
4 期
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSSOvarian Hyperstimulation SyndromeNCT02670304First Affiliated Hospital, Sun Yat-Sen University100
尚未招募
3 期
The Letrozole Administration During Luteal PhaseOvarian Hyperstimulation SyndromeNCT02686151The Affiliated Hospital of Inner Mongolia Medical University50