NL-OMON31795已完成2 期
RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER - Capecitabine vs hormonal treatment
ederlands Kanker Instituut0 个研究点目标入组 128 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent.
- •2. Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
- •3. Positive estrogen receptor (>= 10% positive nuclei at immunohistochemistry). Progesteron and HER-2 neu receptor have to be known.
- •4. - Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed.
- •- Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
- •5. No prior chemotherapy for metastatic disease
- •6. Willing and able to participate in Quality of Life investigation
排除标准
- •1. Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
- •2. Pregnancy or breast feeding women.
- •3. Contra-indications to the use of capecitabine
- •4. Known CNS metastases
研究者
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