EUCTR2012-000174-37-ES进行中（未招募）不适用
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. - Rxponder
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 个研究点目标入组 3,500 人开始时间: 2012年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,500
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. Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes)
- •invasive breast carcinoma with positive estrogen and/or progesterone receptor status,
- •and negative HER-2, as determined by IHC or non-amplified FISH or CISH for screening.
- •2. Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph
- •node dissection (ALND). Patients must have at least one, but no more than three known
- •positive lymph nodes.
- •3. Recurrence score (RS) by Oncotype DX® must be ? 25.
- •4. Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). Patients must
- •have clear margins.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patients must not have inflammatory breast cancer and must not have metastatic
- •disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy
- •alone (no therapeutic radiation or endocrine therapy).
- •2. Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
研究者
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