NCT06418126

Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer

Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Centre Paul Strauss · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	blood sampling before radiotherapy	A blood sample (20 ml) will be taken prior to radiotherapy
BIOLOGICAL	blood sampling after the fourth radiotherapy session	A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
OTHER	collection of acute toxicity (radiodermatitis)	for the entire duration of radiotherapy
OTHER	collection of late toxicity	every year for 5 years
OTHER	collection of disease status	throughout the study
RADIATION	Radiotherapy - Breast +/- lymph node areas	40.05 Gy in 15 fractions of 2.67 Gy, one fraction per week, 5 days per week Or 50 Gy in 25 fractions of 2 Gy, one fraction per week, 5 days per week
RADIATION	Radiotherapy - Boost operating bed	10 Gy in 4 fractions of 2.5 Gy, one fraction per week, 5 days per week Or 16 Gy in 8 fractions of 2 Gy, one fraction per week, 5 days per week

Timeline

• Start date: 2024-01-11
• Primary completion: 2025-10-07
• Completion: 2030-08-19
• First posted: 2024-05-16
• Last updated: 2026-01-05

Locations

1 site across 1 country: France