Breast CancerNCT07404462
Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer
An observational study of Breast Cancer and Early Breast Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Early Breast Cancer
- What is being tested?
- Standard-of-Care Neoadjuvant Chemotherapy
- How many people
- 171 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2017to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients with histologically confirmed early breast cancer treated at the Institute of Oncology Ljubljana who are candidates for standard-of-care neoadjuvant chemotherapy. Participants are enrolled prospectively and followed through surgery and subsequent follow-up to assess pathological complete response (pCR) and associations with tumor-infiltrating lymphocytes and circulating biomarkers.
Who may be able to join
- Female patients aged 18 years or older.
- Histologically confirmed early breast cancer.
- Candidates for standard neoadjuvant chemotherapy.
- Ability to provide informed consent.
Who cannot join
- Luminal A subtype of breast cancer.
- Prior systemic therapy for breast cancer.
- Serious comorbid conditions that would preclude study participation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Standard-of-Care Neoadjuvant Chemotherapy
- Keywords
- Neoadjuvant Chemotherapy, Early 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.
Standard-of-Care Neoadjuvant ChemotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy | Patients with early breast cancer receiving standard-of-care neoadjuvant chemotherapy according to institutional and international guidelines. Treatment is determined by the treating physician and is not assigned by the study protocol. Receives: Other: Standard-of-Care Neoadjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Measured: At surgery following completion of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2017
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
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
- NCT07404462
- Sponsor's protocol ID
- ERIDKE-0054/2023
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07404462
- Acronym / sponsor ID
- ERIDKE-0054/2023
- Conditions
- Breast Cancer, Early Breast Cancer
- Keywords
- Neoadjuvant Chemotherapy, Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 11 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy | – | Other: Standard-of-Care Neoadjuvant ChemotherapyPatients with early breast cancer receiving standard-of-care neoadjuvant chemotherapy according to institutional and international guidelines. Treatment is determined by the treating physician and is not assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with histologically confirmed early breast cancer treated at the Institute of Oncology Ljubljana who are candidates for standard-of-care neoadjuvant chemotherapy. Participants are enrolled prospectively and followed through surgery and subsequent follow-up to assess pathological complete response (pCR) and associations with tumor-infiltrating lymphocytes and circulating biomarkers.
Key inclusion criteria (4 listed)
- Female patients aged 18 years or older.
- Histologically confirmed early breast cancer.
- Candidates for standard neoadjuvant chemotherapy.
- Ability to provide informed consent.
Key exclusion criteria (3 listed)
- Luminal A subtype of breast cancer.
- Prior systemic therapy for breast cancer.
- Serious comorbid conditions that would preclude study participation.
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 |
|---|---|---|
| Standard-of-Care Neoadjuvant ChemotherapyStandard 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. | Other | Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy |
Primary outcome
Pathological Complete Response (pCR)
Time frame: At surgery following completion of neoadjuvant chemotherapy
Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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?
An observational study of Breast Cancer and Early 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: At surgery following completion of neoadjuvant chemotherapy). 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 19 Feb 2026.