Predicting radiotherapy outcomes in triple-negative breast cancer patients
Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023
This study is testing if certain blood markers can help predict which patients with triple-negative breast cancer are at risk of their cancer coming back after radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de cancérologie Strasbourg Europe Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06418126 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers that can predict the risk of recurrence in patients with triple-negative breast cancer (TNBC) undergoing radiotherapy. By analyzing the levels of specific inflammatory cytokines (IL-1β, IL-5, and IL-6) in blood samples taken before and after radiotherapy sessions, researchers hope to differentiate between patients at high risk of early recurrence and those who respond well to treatment. The study will also collect data on acute and late toxicity from the treatment, as well as disease status over time.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and over with pathologically confirmed triple-negative breast cancer who are undergoing neo- or adjuvant chemotherapy followed by radiotherapy.
Not a fit: Patients with distant metastasis at diagnosis, pregnant or breastfeeding women, and those unable to provide consent or communicate in French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment plans for TNBC patients, improving outcomes by identifying those at higher risk of recurrence.
How similar studies have performed: While there have been studies exploring biomarkers in cancer treatment, this specific approach to predicting recurrence in TNBC through cytokine levels is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Strasbourg
- Institut de cancérologie Strasbourg europe — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Valérie SARTORI
- Email: v.sartori@icans.eu
- Phone: 0368767223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.