Clinical trial · Observational
Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
- timeFrame
- 8 years
- description
- \- Plasma concentrations of a set of proteins at diagnosis (measured in g/L)
- measure
- Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
- timeFrame
- 8 years
- description
- \- Time to metastatic relapse
Secondary outcomes (12)
- measure
- Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy
- timeFrame
- 8 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age \> 18 years * Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer * Patient able to understand the French language * Patient affiliated to social security * Obtaining signed written consent Exclusion Criteria: * Persons deprived of their freedom or under guardianship or incapable of giving consent * Refusal to participate
References
Publications (2)
- DERIVEDPinard C, Ginzac A, Molnar I, Veyssiere H, Bidet Y, Sapin V, Durif J, Abrial C, Penault-Llorca F, Durando X, Radosevic-Robin N. Identification of serum proteins associated with response of triple-negative breast cancer to neoadjuvant chemotherapy: preliminary results from the INSTIGO trial. Clin Proteomics. 2025 Dec 29;22(1):50. doi: 10.1186/s12014-025-09574-0. PMID 41462069
- DERIVEDVeyssiere H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021. PMID 34249690