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NCT Number: NCT06418126

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

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.

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Key information

Conditions

Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de cancérologie Strasbourg europe

Strasbourg, 67033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling before radiotherapy

Biological

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

blood sampling after the fourth radiotherapy session

Biological

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

collection of acute toxicity (radiodermatitis)

Other

for the entire duration of radiotherapy

collection of late toxicity

Other

every year for 5 years

collection of disease status

Other

throughout the study

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

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

Primary outcomes

  1. Predictive value of recurrence associated with the appearance of inflammatory cytokines

    Time frame: 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 outcomes

  1. To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.

    Time frame: 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.

  2. 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.

    Time frame: up to 5 years

    Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Registry information

Official study title

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

Acronym: TNBC-RT2023

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
May 16, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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