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临床试验/CTRI/2026/02/103319
CTRI/2026/02/103319尚未招募不适用

VALIDATION OF BIOMARKER PANEL QBM BrCa 1 IN PRE TREATMENT BIOPSIES TO PREDICT NEO ADJUVANT CHEMOTHERAPEUTIC RESPONSE IN TRIPLE NEGATIVE BREAST CANCER

Quantbiomed Private Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月2日最近更新:

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

发起方
Quantbiomed Private Ltd.
申办方类型
Contract research organization
责任方
Principal Investigator
主要研究者

Prof. Arup Chakraborty

Medical College Kolkata

研究点 (1)

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