Clinical trial · Interventional
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
- 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)
Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment. At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers. The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling after the fourth radiotherapy session | Biological | — | UNRESOLVED |
| blood sampling before radiotherapy | Biological | — | UNRESOLVED |
| collection of acute toxicity (radiodermatitis) | Other | — | UNRESOLVED |
| collection of disease status | Other | — | UNRESOLVED |
| collection of late toxicity | Other | — | UNRESOLVED |
| Radiotherapy - Boost operating bed | Radiation | — | UNRESOLVED |
| Radiotherapy - Breast +/- lymph node areas | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women with TNBC breast cancer
- description
- Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session. They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.
- interventionNames
- Biological: blood sampling before radiotherapy
- Biological: blood sampling after the fourth radiotherapy session
- Other: collection of acute toxicity (radiodermatitis)
- Other: collection of late toxicity
- Other: collection of disease status
- Radiation: Radiotherapy - Breast +/- lymph node areas
- Radiation: Radiotherapy - Boost operating bed
Primary outcomes (1)
- measure
- Predictive value of recurrence associated with the appearance of inflammatory cytokines
- timeFrame
- up to 5 years
- description
- Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Women with TNBC breast cancer who meet the following criteria: * Women aged 18 and over; * Any tumor size (pT stage); * Regional lymph node pN0 to pN3; * Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative); * Neo- or adjuvant chemotherapy followed by radiotherapy; * No evidence of distant metastasis at time of diagnosis; * Primary tumor removed by conservative surgery with negative margins; * Patient covered by the French social security system (for French patients). Exclusion Criteria: * Distant metastasis at the time of diagnosis; * Pregnant or breast-feeding women; * Woman deprived of liberty, under guardianship or trusteeship. * Patient unable to give consent * Patient unable to speak French * Patients unable to undergo regular long-term surveillance.
References
Publications (0)
Data not yet available