Clinical trial · Interventional
Immune Tumor Stroma Factors and Pathologic Complete Response After Neoadjuvant Chemotherapy in Early Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Neoadjuvant Chemotherapy for Early Breast Cancer
- 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.
- interventionNames
- Drug: Neoadjuvant Chemotherapy
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- After completion of neoadjuvant chemotherapy (at surgery)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available