Blood and tumor markers that may predict response to treatment in triple-negative breast cancer
Looks for metabolic markers of treatment response in adults with triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: Emergence of Predictive Metabolomic Biomarkers of Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer.
Key facts
- Where
- Nice, FranceSee the site
Where in France
- Centre Antoine LacassagneNice, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Antoine Lacassagne
- Trial code
- NCT07847398
- Record updated
- 29 September 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: Patient who has undergone primary surgery; Dual antiplatelet therapy: Acetylsalicylic acid + Clopidogrel without the possibility of suspending Clopidogrel for 5 days,; 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; 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; Patient taking:; Ticagrelor without the possibility of suspension for 5 days,; Prasugrel without the possibility of suspension for 7 days,.