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

NCT06418126 | Active Not Recruiting

• 1 other identifier: 2023-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-negative Breast Cancer

Keywords

Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Biological: blood sampling before radiotherapy; Biological: blood sampling after the fourth radiotherapy session; Other: collection of acute toxicity (radiodermatitis); Other: collection of late toxicity; Other: collection of disease status; Radiation: Radiotherapy - Breast +/- lymph node areas; Radiation: Radiotherapy - Boost operating bed

Interventions

blood sampling before radiotherapy BIOLOGICAL

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

Women with TNBC breast cancer

blood sampling after the fourth radiotherapy session BIOLOGICAL

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

Women with TNBC breast cancer

collection of acute toxicity (radiodermatitis) OTHER

for the entire duration of radiotherapy

Women with TNBC breast cancer

collection of late toxicity OTHER

every year for 5 years

Women with TNBC breast cancer

collection of disease status OTHER

throughout the study

Women with TNBC breast cancer

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

Women with TNBC breast cancer

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

Women with TNBC breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Paul Strauss: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Study Sites (1)

Institut de cancérologie Strasbourg europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 16, 2024
• Study Start: January 11, 2024
• Primary Completion: October 7, 2025
• Study Completion (Estimated): August 19, 2030
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)