NCT06418126Active, not recruiting
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 · Last updated 5 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 11 Apr 2024
- Start date
- 11 Jan 2024
- Primary completion date
- 7 Oct 2025
- Lead sponsor
- Centre Paul Strauss
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06418126
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 11 Jan 2024 to the primary completion date, 7 Oct 2025
- 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.
Other
- 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.
Who the study is looking for
- 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).
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 |
|---|---|---|---|
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.