NCT07407244

Immune Tumor Stroma Factors and Pathologic Complete Response After Neoadjuvant Chemotherapy in Early Breast Cancer

Study AKRA: Correlation of Immune-Related Tumor Stroma Factors With Complete Pathologic Remission in Early Breast Cancer After Neoadjuvant Chemotherapy and With Circulating Tumor Cells/Circulating Tumor DNA

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study aims to identify immune-related predictive factors of response to neoadjuvant chemotherapy in patients with early breast cancer. The study will evaluate immune markers in tumor stroma and blood samples collected before treatment to determine their association with complete pathological remission (pCR). In addition, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) will be analyzed to explore their correlation with treatment response. The results may contribute to improved selection of patients who are most likely to benefit from neoadjuvant chemotherapy.

Detailed description

This prospective observational cohort study investigates the relationship between immune-related tumor stroma factors and response to neoadjuvant chemotherapy (NACT) in patients with early breast cancer treated at the Institute of Oncology Ljubljana. The primary objective is to identify immune predictive markers in the tumor microenvironment that are associated with achieving pathological complete remission (pCR) after neoadjuvant chemotherapy. Tumor tissue and blood samples will be analyzed to evaluate immune-related biomarkers and their prognostic and predictive value. In addition, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) will be assessed in peripheral blood samples collected before initiation of treatment, in order to determine their association with immune-related tumor stroma characteristics and clinical outcomes. The study aims to improve understanding of biological mechanisms influencing treatment response and may support future personalized treatment strategies by identifying patients who are most likely to benefit from neoadjuvant chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy	Standard neoadjuvant chemotherapy administered to patients with early breast cancer according to institutional protocols. Treatment is not experimental and is part of routine clinical care. Immune-related tumor stroma factors and blood biomarkers will be analyzed in relation to pathological complete response (pCR) and circulating tumor cells/circulating tumor DNA.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-03-31
• Completion: 2026-02-28
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: Slovenia