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Trial Title:
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer
NCT ID:
NCT06418126
Condition:
Triple-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
blood sampling before radiotherapy
Description:
A blood sample (20 ml) will be taken prior to radiotherapy
Arm group label:
Women with TNBC breast cancer
Intervention type:
Biological
Intervention name:
blood sampling after the fourth radiotherapy session
Description:
A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.
Arm group label:
Women with TNBC breast cancer
Intervention type:
Other
Intervention name:
collection of acute toxicity (radiodermatitis)
Description:
for the entire duration of radiotherapy
Arm group label:
Women with TNBC breast cancer
Intervention type:
Other
Intervention name:
collection of late toxicity
Description:
every year for 5 years
Arm group label:
Women with TNBC breast cancer
Intervention type:
Other
Intervention name:
collection of disease status
Description:
throughout the study
Arm group label:
Women with TNBC breast cancer
Intervention type:
Radiation
Intervention name:
Radiotherapy - Breast +/- lymph node areas
Description:
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
Arm group label:
Women with TNBC breast cancer
Intervention type:
Radiation
Intervention name:
Radiotherapy - Boost operating bed
Description:
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
Arm group label:
Women with TNBC breast cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de cancérologie Strasbourg europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Valérie SARTORI
Phone:
0368767223
Phone ext:
33
Email:
v.sartori@icans.eu
Contact backup:
Last name:
Manon VOEGELIN
Phone:
0368767360
Phone ext:
33
Email:
promotion-rc@icans.eu
Investigator:
Last name:
Georges NOEL
Email:
Principal Investigator
Start date:
January 11, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Institut de cancérologie Strasbourg Europe
Agency class:
Other
Collaborator:
Agency:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Agency class:
Other
Source:
Institut de cancérologie Strasbourg Europe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418126
