VALIDATION OF BIOMARKER PANEL QBM BrCa 1 IN PRE TREATMENT BIOPSIES TO PREDICT NEO ADJUVANT CHEMOTHERAPEUTIC RESPONSE IN TRIPLE NEGATIVE BREAST CANCER
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pathological complete response and residual cancer burden in post-surgical tissues after completing neo-adjuvant chemotherapy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients with early stage triple-negative breast cancer.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pathological complete response and residual cancer burden in post-surgical tissues after completing neo-adjuvant chemotherapy
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Arup Chakraborty
Medical College Kolkata
