CTRI/2023/09/057359尚未招募2 期
Estrogen Receptor-Beta & TP53 Status as prognostic markers in Triple Negative Breast Cancer and their clinical outcomes with Tamoxifen(Selective Estrogen Receptor Modulator)
NAVNEET KAILASH AGRAWAL1 个研究点 分布在 1 个国家入组 100 人开始时间: 2023年9月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study will evaluate the efficacy of adding Tab Tamoxifen 20mg OD in addition to standard treatment in Triple Negative Breast Cancer patients having ER Beta positive with TP53 mutation.The patients with Estrogen Beta receptor negative and/or with TP53 wild type will be given the standard treatment for Triple Negative Breast Cancer.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- All triple negative breast cancer patients will be included 2)All stages of breast cancer patients will be included.
排除标准
- Luminal Breast Cancer patients 2)Pregnant females 3)Breastfeeding females 4)Patients receiving olaparib.
结局指标
主要结局
Progression free survival
时间窗: Between date of study entry and date of progression or death due to any cause for upto 24 months after therapy start
次要结局
- Overall survival(Between date of study entry and date of death due to any cause after therapy start)
研究者
研究点 (1)
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标识符
- CTRI 编号
- CTRI/2023/09/057359
日期
- 最近更新
- (3年前)
监管与共享
- 个体参与者数据共享计划
- 否
Will individual participant data (IPD) be shared publicly (including data dictionaries)? Response - NO
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