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Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer
Sponsor: Centre Paul Strauss
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.
Official title: Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-01-11
Completion Date
2030-08-19
Last Updated
2026-01-05
Healthy Volunteers
No
Conditions
Interventions
blood sampling before radiotherapy
A blood sample (20 ml) will be taken prior to radiotherapy
blood sampling after the fourth radiotherapy session
A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
collection of acute toxicity (radiodermatitis)
for the entire duration of radiotherapy
collection of late toxicity
every year for 5 years
collection of disease status
throughout the study
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
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
Locations (1)
Institut de cancérologie Strasbourg europe
Strasbourg, France