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

Centre Paul Strauss

Status

Active, not recruiting

Conditions

Triple-negative Breast Cancer

Treatments

Other: collection of disease status

Biological: blood sampling before radiotherapy

Radiation: Radiotherapy - Boost operating bed

Biological: blood sampling after the fourth radiotherapy session

Other: collection of late toxicity

Radiation: Radiotherapy - Breast +/- lymph node areas

Other: collection of acute toxicity (radiodermatitis)

Study type

Interventional

Funder types

Other

Identifiers

NCT06418126

2023-003

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Women with TNBC breast cancer

Experimental group

Description:

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.