Breast CancerAKRANCT07407244
Immune Tumor Stroma Factors and Pathologic Complete Response After Neoadjuvant Chemotherapy in Early Breast Cancer
A study testing Neoadjuvant Chemotherapy in people with Breast Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2017to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Male breast cancer
- Patients without neoadjuvant chemotherapy
- Inability or refusal to provide informed consent
- Insufficient biological material for analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Neoadjuvant Chemotherapy
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy for Early Breast Cancer | Other | 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. Receives: Drug: Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
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).
Measured: After completion of neoadjuvant chemotherapy (at surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Mar 2017
- Primary completion31 Mar 2017
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407244
- Sponsor's protocol ID
- OIL_AKRA _EBC
- Other IDs
- P3-0321
- Acronym
- AKRA
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07407244
- Acronym / sponsor ID
- AKRA / OIL_AKRA _EBC
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy for Early Breast Cancer | Other | Drug: Neoadjuvant ChemotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Male breast cancer
- Patients without neoadjuvant chemotherapy
- Inability or refusal to provide informed consent
- Insufficient biological material for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant ChemotherapyStandard 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. | Drug | Neoadjuvant Chemotherapy for Early Breast Cancer |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant Chemotherapy in people with Breast Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: After completion of neoadjuvant chemotherapy (at surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.