Paired targeted genomic profiling of triple negative breast cancer to understand the mechanisms of chemoresistance and develop novel treatment targets
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of targetable mutations in residual disease in triple negative breast cancer that were not initially present in the tumor cells and in germline
研究概览
简要总结
It is expected that 232,832 patients will be diagnosed with breast cancer in India in 2025. Triple-negative breast cancer (TNBC) is a subtype that does not express estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) andtherefore, such patients do not benefit from hormonal or HER2 directed
therapy.
The current standard of management of patients with TNBC more than 2 cm primary tumor size is neoadjuvant chemotherapy, followed by surgery and subsequently radiotherapy, as indicated. Despite this, around 50% of patients with TNBC will eventually developchemoresistance, recur systemically and succumb to cancer.
The mechanisms of chemoresistance in the residual tumor tissue are not known. To addressthis knowledge gap, we aim to compare the targeted genomic (germline and somatic) profiles of baseline tumor samples with that of post-neoadjuvant chemotherapy surgical specimenfrom a prospective cohort of patients with TNBC.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients diagnosed with triple negative breast cancer Non metastatic disease Planned for neoadjuvant chemotherapy Willing to participate in study.
排除标准
- •Patients with prior history of cancer Patients planned for upfront surgery.
结局指标
主要结局
Identification of targetable mutations in residual disease in triple negative breast cancer that were not initially present in the tumor cells and in germline
时间窗: Six months
次要结局
- Identifying the associations between differential mutations with disease-free survival of patients with triple negative breast cancer(Identification of genetic mutations associated with incomplete response to chemotherapy)