An interventional study of blood sampling before radiotherapy and blood sampling after the fourth radiotherapy session in Triple-negative Breast Cancer, sponsored by Centre Paul Strauss. Active, not recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Centre Paul Strauss · Not applicable, Interventional, and Other
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.
1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.
This study's planned enrollment of 15 is below the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Centre Paul Strauss is the lead sponsor of 30 studies on the registry; 20 are open to participants now.
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Women with TNBC breast cancer who meet the following criteria:
Exclusion Criteria:
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.
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
A blood sample (20 ml) will be taken prior to radiotherapy
A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
for the entire duration of radiotherapy
every year for 5 years
throughout the study
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
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
Predictive value of recurrence associated with the appearance of inflammatory cytokines
Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.
Time frame: up to 5 years
To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.
TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion.
Time frame: up to 5 years
To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence.
Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.
Time frame: up to 5 years
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Triple Negative Breast Neoplasms→
Centre Paul Strauss