NCT07847398Not yet recruiting
Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- May 2029
- Lead sponsor
- Centre Antoine Lacassagne
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07847398
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Oct 2026 to the primary completion date, May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who has undergone primary surgery.
- Dual antiplatelet therapy: Acetylsalicylic acid + Clopidogrel without the possibility of suspending Clopidogrel for 5 days,
Other illness
- Metastatic breast cancer documented by staging workup (PET scan or thoraco-abdomino-pelvic CT scan + bone scan).
- Patient presenting with multiple primary malignant tumors.
- Patient with HIV infection, Hepatitis C, or active Hepatitis B.
Lab values
- INR \< 1.5; Platelets \< 50,000/$\\mu$L.
- Vitamin K antagonists (acenocoumarol, warfarin, or fluindione) with INR \< 2 or \> 3, without the possibility of suspension.
Other
- Patient taking:
- Ticagrelor without the possibility of suspension for 5 days,
- Prasugrel without the possibility of suspension for 7 days,
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.