Skip to main content
Clinical Trials/CTRI/2026/02/103319
CTRI/2026/02/103319Not yet recruitingNot Applicable

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 site in 1 country20 target enrollmentStarted: March 2, 2026Last updated:

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

Sponsor
Quantbiomed Private Ltd.
Sponsor Class
Contract research organization
Responsible Party
Principal Investigator
Principal Investigator

Prof. Arup Chakraborty

Medical College Kolkata

Study Sites (1)

Loading locations...

Similar Trials