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Not yet recruitingNCT07847398EMMENEO-TNUpdated Sep 29, 2026

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

An interventional study of Blood sampling and Tumor sampling in Triple-negative Breast Cancer (TNBC), Stage II-III, sponsored by Centre Antoine Lacassagne. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Triple-negative Breast Cancer (TNBC), Stage II-III
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 years or older.
  • Female patient with stage II and III triple-negative breast cancer, requiring neoadjuvant chemo-immunotherapy according to the KEYNOTE-522 regimen or any neoadjuvant treatment including chemotherapy and immunotherapy validated in standard care or a clinical trial, regardless of the treatment regimen (ER \< 10%, PR \< 10%, HER2 0, and HER2 low).
  • Patient requiring the placement of a localization clip as part of their standard clinical care management.
  • Patient who has read the information sheet and signed the informed consent.
  • Patient affiliated with a Social Security health insurance scheme.

Exclusion criteria

Exclusion Criteria:

  • Metastatic breast cancer documented by staging workup (PET scan or thoraco-abdomino-pelvic CT scan + bone scan).
  • Patient who has undergone primary surgery.
  • INR \< 1.5; Platelets \< 50,000/$\mu$L.
  • Patient presenting with multiple primary malignant tumors.
  • Patient with HIV infection, Hepatitis C, or active Hepatitis B.
  • Patient taking:
  • Dual antiplatelet therapy: Acetylsalicylic acid + Clopidogrel without the possibility of suspending Clopidogrel for 5 days,
  • Ticagrelor without the possibility of suspension for 5 days,
  • Prasugrel without the possibility of suspension for 7 days,
  • Vitamin K antagonists (acenocoumarol, warfarin, or fluindione) with INR \< 2 or > 3, without the possibility of suspension.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Neoadjuvant chemo-immunotherapy

    Patients receiving neoadjuvant chemo-immunotherapy according to the study protocol.

    Biological: Blood sampling · Procedure: Tumor sampling

Interventions

  • BiologicalBlood 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.

  • ProcedureTumor 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.

05

What researchers measure

Primary outcomes

  1. Predictive performance of targeted metabolites and histological response

    The predictive performance of targeted metabolites (tryptophan pathway and diacetylspermine) to predict post-surgical histological response will be evaluated using the area under the ROC curve (AUC), with an AUC target \> 0.8. Histological response will be assessed according to the Residual Cancer Burden (RCB) classification, ranging from RCB0 (pathological complete response) to RCB3 (presence of extensive residual disease), based on the results obtained from the surgical specimen of breast surgery.

    Time frame: From enrollment to the end of treatment and follow-up - 8 months.

  2. Consistency of metabolites between plasma and tumor biopsies

    The consistency of variations in metabolites of interest between plasma samples and tumor biopsies will be evaluated by a semi-quantitative correlation between the two compartments.

    Time frame: From enrollment to the end of treatment and follow-up - 8 months.

Secondary outcomes

  1. Performance of a metabolomic signature using machine learning

    The performance of a metabolomic signature (untargeted analysis), established notably using machine learning methods, to predict post-surgical histological response will be evaluated by the AUC, with a target \> 0.8.

    Time frame: From enrollment to the end of treatment and follow-up - 8 months.

  2. Variations of tryptophan pathway metabolites

    Variations in tryptophan pathway metabolites will be evaluated by semi-quantitative correlation with the clinical-biological response.

    Time frame: From enrollment to the end of treatment and follow-up - 8 months.

  3. Prediction of radiological response by targeted metabolites

    The predictive performance of targeted metabolites to predict radiological response to neoadjuvant chemo-immunotherapy will be evaluated by the AUC, with a target \> 0.8.

    Time frame: From enrollment to the end of treatment and follow-up - 8 months.

06

Study locations

1 site
07

Registry details

Key details

Study ID
NCT07847398
Lead sponsor
Centre Antoine Lacassagne
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Oct 2026 (estimated)
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Sep 29, 2026

Study contacts

Study coordinator
Contact
DRCI-Promotion@nice.unicancer.fr
+33 (0)4 92 03 17 78
Caroline BAILLEUX
principal investigator · Centre Antoine Lacassagne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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