Skip to main content
Clinical Trials/NCT06950671
NCT06950671Not yet recruitingNot Applicable

Role of TREM-1 as a Novel Biomarker in HER-2 Negative Breast Cancer: a Molecular and Clinical Study

Rahma Esam Salama Esawi1 site in 1 country1 target enrollmentStarted: September 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
1
Locations
1
Primary Endpoint
: assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS

Study Overview

Brief Summary

Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.

Detailed Description

a prospective observational cohort study on the role of TREM-1 as a novel immune biomarker in HER-2 breast cancer it's a molecular and clinical study. our aim is to assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS and to quantify TREM-1 expression and correlate its level with clinical and pathological response to neo-adjuvant treatment. and evaluate its association with immune cells (eg. monocytes and neutrophils)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •female patient aged < 18 yrs. old
  • •histological proven breast cancer
  • •HER-2 negative (hormonal positive or triple negative)
  • •planned to receive neo-adjuvant therapy
  • •complete clinical, radiological and therapeutic data

Exclusion Criteria

  • •metastatic breast cancer
  • •HER-2 positive
  • •incomplete clinical, radiological or therapeutic data

Outcomes

Primary Outcomes

: assess prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS & OS

Time Frame: follow up patients over 2 years

prognostic significance of TREM-1 expression at baseline and post neo-adjuvant treatment regards DFS \& OS

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Rahma Esam Salama Esawi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rahma Esam Salama Esawi

Role of TREM-1 as a novel biomarker in HER-2 breast cancer : a molecular and clinical study

Assiut University

Study Sites (1)

Loading locations...

Similar Trials