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

February 12, 2026 updated by: Institute of Oncology Ljubljana

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Neoadjuvant Chemotherapy for Early Breast Cancer
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR)
Time Frame: After completion of neoadjuvant chemotherapy (at surgery)
To determine immune-related predictive factors of response to neoadjuvant chemotherapy in the tumor stroma of patients with early breast cancer, in relation to achieving pathological complete response (pCR).
After completion of neoadjuvant chemotherapy (at surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 31, 2017

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OIL_AKRA _EBC
  • P3-0321 (Other Identifier: ARIS (Slovenian Research and Innovation Agency))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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