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

Institute of Oncology Ljubljana

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Drug: Neoadjuvant Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07407244

OIL_AKRA _EBC

P3-0321 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with early breast cancer
• Planned neoadjuvant chemotherapy (NACT)
• Availability of tumor tissue sample (biopsy) before treatment
• Ability to provide blood sample(s)
• Signed informed consent

Exclusion criteria

• Male breast cancer
• Patients without neoadjuvant chemotherapy
• Inability or refusal to provide informed consent
• Insufficient biological material for analysis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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268 participants in 1 patient group

Neoadjuvant Chemotherapy for Early Breast Cancer

Other group

Description:

Patients with early breast cancer receiving standard neoadjuvant chemotherapy will be followed to assess immune-related tumor stroma factors and blood biomarkers in association with complete pathologic remission (pCR) and circulating tumor cells/circulating tumor DNA.

Treatment:

Drug: Neoadjuvant Chemotherapy