Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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).

Locations
Other Locations
France
Institut de cancérologie Strasbourg europe
RECRUITING
Strasbourg
Contact Information
Primary
Valérie SARTORI
v.sartori@icans.eu
0368767223
Backup
Manon VOEGELIN
promotion-rc@icans.eu
0368767360
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 15
Treatments
Experimental: Women with TNBC breast cancer
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Leads: Institut de cancérologie Strasbourg Europe

This content was sourced from clinicaltrials.gov