Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study

NCT06950671 | Not Yet Recruiting DMC

• 1 other identifier: novel biomarker in cancer
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Invasive

Keywords

TREM-1 in non metastatic HER-2 negative breast cancer

Outcome Measures

Primary Outcomes (1)

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

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

  follow up patients over 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

female patients with HER-2 breast cancer not metastatic planned to receive neoadjuvant therapy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rahma Esam Salama Esawi: lead
• Assiut University: collaborator

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt, 71631, Egypt

Location

Related Publications (1)

• Pullikuth AK, Routh ED, Zimmerman KD, Chifman J, Chou JW, Soike MH, Jin G, Su J, Song Q, Black MA, Print C, Bedognetti D, Howard-McNatt M, O'Neill SS, Thomas A, Langefeld CD, Sigalov AB, Lu Y, Miller LD. Bulk and Single-Cell Profiling of Breast Tumors Identifies TREM-1 as a Dominant Immune Suppressive Marker Associated With Poor Outcomes. Front Oncol. 2021 Dec 8;11:734959. doi: 10.3389/fonc.2021.734959. eCollection 2021.

  PMID: 34956864 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample will be analyzed by flowctometry

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• summar mohamed summar el-morshidy, lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

rahma esawi Rahma E.Esawi, assistant lecturer

CONTACT

+201020597669; rahmaesam1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Role of TREM-1 as a novel biomarker in HER-2 breast cancer : a molecular and clinical study

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 30, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

EG (1)