NOT YET RECRUITING
NCT07847398
Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.
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.
Gender: FEMALE
Ages: 18 Years - Any
Triple-negative Breast Cancer (TNBC), Stage II-III