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Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.

Study acronym: EMMENEO-TN
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
The goal of this study is to investigate whether specific metabolic profiles can predict response to neoadjuvant chemo-immunotherapy in patients with stage II and III triple-negative breast cancer (TNBC). The main objectives are to determine: * whether targeted metabolic pathways, specifically tryptophan and diacetylspermine metabolism, are associated with histological response to neoadjuvant treatment; * whether untargeted metabolomics combined with machine learning approaches can identify novel biomarkers predictive of treatment response. Participants will: * undergo image-guided tumor sampling during the standard-of-care placement of the tumor localization clip, prior to initiation of neoadjuvant chemo-immunotherapy, in accordance with routine clinical practice at the study center; * provide a blood sample before initiation of neoadjuvant chemo-immunotherapy; * provide a second blood sample during the course of standard treatment; continue to receive routine clinical care, including imaging assessments and surgical management, according to standard clinical practice. The study does not modify the patient's standard therapeutic management.
Trial Details
NCT Number NCT07847398
Lead Sponsor Centre Antoine Lacassagne
Conditions
(from sponsor)
Triple-negative Breast Cancer (TNBC), Stage II-III
Related terms Triple Negative Breast Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov