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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Triple-negative Breast Cancer
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie SARTORI; Phone Number: 33 0368767223; Email: v.sartori@icans.eu
• Study Contact Backup: Name: Manon VOEGELIN; Phone Number: 33 0368767360; Email: promotion-rc@icans.eu

Study Locations

• France
  • Strasbourg, France, 67033
    • Recruiting
    • Institut de cancérologie Strasbourg Europe
    • Contact: Valérie SARTORI; Phone Number: 33 0368767223; Email: v.sartori@icans.eu
    • Contact: Manon VOEGELIN; Phone Number: 33 0368767360; Email: promotion-rc@icans.eu
    • Principal Investigator: Georges NOEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Women with TNBC breast cancer; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.	TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion.	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.	Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.	up to 5 years

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe
• Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 2023-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No