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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with TNBC breast cancer | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling before radiotherapy | Biological | A blood sample (20 ml) will be taken prior to radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 years |
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Inclusion Criteria:
Women with TNBC breast cancer who meet the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de cancérologie Strasbourg europe | Strasbourg | 67033 | France |
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| blood sampling after the fourth radiotherapy session | Biological | A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session. |
|
| collection of acute toxicity (radiodermatitis) | Other | for the entire duration of radiotherapy |
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| collection of late toxicity | Other | every year for 5 years |
|
| collection of disease status | Other | throughout the study |
|
| Radiotherapy - Breast +/- lymph node areas | Radiation | 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 | Radiation | 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 |
|
| 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. |
| up to 5 years |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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