Triple-negative Breast Cancer (TNBC), Stage II-IIIEMMENEO-TNNCT07847398
Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.
A study testing Blood sampling and Tumor sampling in people with Triple-negative Breast Cancer (TNBC), Stage II-III, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-negative Breast Cancer (TNBC), Stage II-III
- What is being tested?
- Blood sampling and Tumor sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Antoine Lacassagne
Nice, 06189
Study coordinator, +33 (0)4 92 03 17 78, DRCI-Promotion@nice.unicancer.fr
About this study
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:
Read more
- 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.
- Being tested
- Blood sampling, Tumor sampling
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
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.
Tumor samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Patients receiving neoadjuvant chemo-immunotherapy according to the study protocol. Receives: Biological: Blood sampling; Procedure: Tumor sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment and follow-up - 8 months.
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.
Measured: From enrollment to the end of treatment and follow-up - 8 months.
Secondary outcomes (3)
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.
Measured: From enrollment to the end of treatment and follow-up - 8 months.
Variations of tryptophan pathway metabolites
Variations in tryptophan pathway metabolites will be evaluated by semi-quantitative correlation with the clinical-biological response.
Measured: From enrollment to the end of treatment and follow-up - 8 months.
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.
Measured: From enrollment to the end of treatment and follow-up - 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast Cancer (TNBC), Stage II-IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline BAILLEUX, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847398
- Sponsor's protocol ID
- 2023/58
- Acronym
- EMMENEO-TN
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT07847398
- Acronym / sponsor ID
- EMMENEO-TN / 2023/58
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Biological: Blood sampling, Procedure: Tumor samplingPatients receiving neoadjuvant chemo-immunotherapy according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingTwo 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. | Biological | Neoadjuvant chemo-immunotherapy |
| Tumor samplingTwo 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. | Procedure or surgery | Neoadjuvant chemo-immunotherapy |
Primary outcome
Predictive performance of targeted metabolites and histological response
Time frame: From enrollment to the end of treatment and follow-up - 8 months.
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.
Consistency of metabolites between plasma and tumor biopsies
Time frame: From enrollment to the end of treatment and follow-up - 8 months.
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.
3 secondary outcomes
Performance of a metabolomic signature using machine learning
Time frame: From enrollment to the end of treatment and follow-up - 8 months.
Variations of tryptophan pathway metabolites
Time frame: From enrollment to the end of treatment and follow-up - 8 months.
Prediction of radiological response by targeted metabolites
Time frame: From enrollment to the end of treatment and follow-up - 8 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline BAILLEUX principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Tumor sampling in people with Triple-negative Breast Cancer (TNBC), Stage II-III, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study coordinator (+33 (0)4 92 03 17 78, DRCI-Promotion@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of targeted metabolites and histological response (time frame: From enrollment to the end of treatment and follow-up - 8 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.