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

Triple-negative Breast Cancer Clinical Trial

— TNBC-RT2023  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418126
• Other study ID #: 2023-003
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Valérie SARTORI
• Phone: 0368767223
• Email: v.sartori[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Biological:
• blood sampling before radiotherapy
A blood sample (20 ml) will be taken prior to radiotherapy
• 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
• collection of late toxicity
every year for 5 years
• 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
• 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

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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