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NOT YET RECRUITING
NCT07847398
NA

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

Sponsor: Centre Antoine Lacassagne

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-10

Completion Date

2029-05

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

Blood sampling

Two blood samples will be collected during neoadjuvant chemo-immunotherapy: one at Cycle 1, Day 1 (C1D1) of Sequence 1, prior to treatment initiation, and one at Cycle 3, Day 1 (C3D1) of Sequence 2, prior to treatment administration. Blood samples will be used for metabolomic analyses of plasma.

PROCEDURE

Tumor sampling

Two tumor core biopsy samples will be collected under radiological guidance during placement of the localization clip, prior to initiation of neoadjuvant chemo-immunotherapy, in accordance with standard procedures at the study site. One core will be used for pathological confirmation of tumor tissue and the other will be collected for research purposes and used for subsequent molecular analyses.

Locations (1)

Centre Antoine Lacassagne

Nice, France