Triple-negative Breast Cancer
Conditions
Keywords
Radiotherapy
Brief 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.
Interventions
BIOLOGICALblood sampling before radiotherapy
A blood sample (20 ml) will be taken prior to radiotherapy
BIOLOGICALblood sampling after the fourth radiotherapy session
A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
OTHERcollection of acute toxicity (radiodermatitis)
for the entire duration of radiotherapy
OTHERcollection of late toxicity
every year for 5 years
OTHERcollection of disease status
throughout the study
RADIATIONRadiotherapy - 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
RADIATIONRadiotherapy - 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
Sponsors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre Paul Strauss
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive value of recurrence associated with the appearance of inflammatory cytokines | up to 5 years | Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence. | up to 5 years | TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion. |
| 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. | up to 5 years | Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice. |
Countries
France
Outcome results
None listed