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| ID | Type | Description | Link |
|---|---|---|---|
| P3-0321 | Other Identifier | ARIS (Slovenian Research and Innovation Agency) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After completion of neoadjuvant chemotherapy (at surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| D017437 |
| Skin and Connective Tissue Diseases |