NCT07404462

Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the correlation between immune-related factors in the tumor stroma and pathological complete response (pCR) in patients with early breast cancer treated with neoadjuvant chemotherapy. In addition, the study evaluates the association between immune-related tumor stroma factors and the presence of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in peripheral blood. The study includes serial blood sampling before and after treatment and during follow-up to assess the prognostic value of these biomarkers for disease progression and recurrence.

Detailed description

Neoadjuvant chemotherapy is widely used in patients with early breast cancer to reduce tumor size and improve surgical outcomes. Achieving a pathological complete response (pCR) is associated with improved prognosis; however, reliable predictive biomarkers are still limited. Recent evidence suggests that immune cells in the tumor microenvironment may influence treatment response. This study evaluates immune-related tumor stroma factors (including tumor-infiltrating lymphocytes and immune marker profiles) in tumor tissue obtained prior to treatment. In parallel, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) are assessed from peripheral blood samples collected before neoadjuvant chemotherapy, after completion of treatment, and during follow-up. The primary objective is to determine whether immune-related tumor stroma factors correlate with pCR after neoadjuvant chemotherapy. Secondary objectives include evaluating the association of immune-related factors with the presence of CTCs and ctDNA and assessing their prognostic value for disease progression and recurrence.

Conditions

• Breast Cancer
• Early Breast Cancer

Interventions

Type	Name	Description
OTHER	Standard-of-Care Neoadjuvant Chemotherapy	Standard neoadjuvant chemotherapy administered as part of routine clinical care. The regimen is determined by the treating physician and is not assigned by the study protocol.

Timeline

• Start date: 2017-03-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2026-02-11
• Last updated: 2026-02-19

Locations

1 site across 1 country: Slovenia