CTRI/2025/01/079814招募中2 期
Neoadjuvant Concurrent Chemoradiation Therapy in the Locally Advanced Triple-Negative Breast Cancer Population: A Prospective Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To assess the tolerability of treatment regimen
研究概览
简要总结
This research explores how well a combination of chemotherapy and radiation therapy works in treating triple-negative breast cancer when given before surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Biopsy proven unilateral locally advanced triple negative breast cancer which includes Stage IIIA-C &/or oligometastastic disease which is defined by ESTRO/ESMO/ACOG as a disease with up to 5 lesions each amenable to local therapy aimed at achieving no evidence of disease status.
排除标准
- •Unwilling for mastectomy, previous irradiation to chest wall, multiple visceral/bone metastasis, renal cardiac dysfunction, uncontrolled diabetes, bilateral breast cancer, recurrence of tumour.
结局指标
主要结局
To assess the tolerability of treatment regimen
时间窗: Patient will be assessed at baseline, during time of chemoradiation, post surgery,and after treatmet at 6 weeks, 8 weeks and 12 weeks
次要结局
- To assess pathological complete response rate (pCR)(pCR report will be available only post surgery (after completion of treatment i.e Neoadjuvant chemoradiation followed by modified radical mastectomy) single time point)
研究者
Jahnabi Das
Dr B Borooah Cancer Institute
研究点 (1)
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