VALIDATION OF BIOMARKER PANEL QBM BrCa 1 IN PRE TREATMENT BIOPSIES TO PREDICT NEO ADJUVANT CHEMOTHERAPEUTIC RESPONSE IN TRIPLE NEGATIVE BREAST CANCER
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pathological complete response and residual cancer burden in post-surgical tissues after completing neo-adjuvant chemotherapy
研究概览
简要总结
Breast cancer response to neoadjuvant chemotherapy (NACT) is influenced by the tumor microenvironment (TME), particularly the presence of specific immune or stromal cell subsets. Using a meta-analytical approach combining multiple transcriptomics datasets, QuantBioMed (QBM) has identified two novel cell subsets within the TME that are predictive of favorable responses to NACT. A biomarker panel, QBM-BrCa-1 has been developed to identify the cell subsets at a protein level from formalin fixed paraffin embedded (FFFPE) tissues. As a next step, we aim to validate the marker in pre-treatment breast tumors and build a scoring system to establish its translational utility in the clinic.Accurate prediction of NACT response can significantly improve treatment planning and outcomes in breast cancer. While several biomarkers have been proposed and used (4), few are directly linked to the stromal and immune architecture at the tissue level. This study aims to validate the spatial presence and abundance of two specific cell subsets using immunofluorescence (IF) and immunohistochemistry (IHC), correlating their presence with treatment response. If validated, these markers may serve as potential tools for clinical decision-making in the management of breast cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients with early stage triple-negative breast cancer.
排除标准
- 未提供
结局指标
主要结局
Pathological complete response and residual cancer burden in post-surgical tissues after completing neo-adjuvant chemotherapy
时间窗: At surgery, 3 to 8 weeks after the last cycle of neo-adjuvant chemotherapy (18 to 24 weeks after starting the first cycle after an initial diagnosis)
次要结局
未报告次要终点
研究者
Prof. Arup Chakraborty
Medical College Kolkata
