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

NCT06418126 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-05

No results posted yet for this study

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.

Conditions

  • Triple-negative Breast Cancer

Interventions

RADIATION

Radiotherapy - 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

RADIATION

Radiotherapy - 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

BIOLOGICAL

blood sampling before radiotherapy

A blood sample (20 ml) will be taken prior to radiotherapy

BIOLOGICAL

blood sampling after the fourth radiotherapy session

A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.

OTHER

collection of acute toxicity (radiodermatitis)

for the entire duration of radiotherapy

OTHER

collection of late toxicity

every year for 5 years

OTHER

collection of disease status

throughout the study

Sponsors & Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER

  • Centre Paul Strauss

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2025-10-07
Completion
2030-08-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418126 on ClinicalTrials.gov