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

Not Applicable

Recruiting

• Conditions: Triple-negative Breast Cancer
• Interventions: 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

• Registration Number: NCT06418126
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-11
• Study First Submitted: 2024-04-11
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with TNBC breast cancer	collection of acute toxicity (radiodermatitis)	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.
Women with TNBC breast cancer	collection of disease status	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.
Women with TNBC breast cancer	blood sampling after the fourth radiotherapy session	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.
Women with TNBC breast cancer	collection of late toxicity	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.
Women with TNBC breast cancer	Radiotherapy - Boost operating bed	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.
Women with TNBC breast cancer	blood sampling before radiotherapy	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.
Women with TNBC breast cancer	Radiotherapy - Breast +/- lymph node areas	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.

Primary Outcome Measures

Name	Time	Method
Predictive value of recurrence associated with the appearance of inflammatory cytokines	up to 5 years	Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.

Secondary Outcome Measures

Name	Time	Method
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	TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion.
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	Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg europe; 🇫🇷 Strasbourg, France