Clinical trial · Observational
Correlation Between Tumor-infiltrating Lymphocytes and Response to Systemic Therapy in Breast Cancer
- 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 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.
Conditions
Conditions (2)
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 |
| Early Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard-of-Care Neoadjuvant Chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Early Breast Cancer Patients Receiving Standard-of-Care Neoadjuvant Chemotherapy
- description
- 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.
- interventionNames
- Other: Standard-of-Care Neoadjuvant Chemotherapy
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- At surgery following completion of neoadjuvant chemotherapy
- description
- Pathological complete response is defined as the absence of invasive carcinoma in the breast and axillary lymph nodes after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years or older. * Histologically confirmed early breast cancer. * Candidates for standard neoadjuvant chemotherapy. * Ability to provide informed consent. Exclusion Criteria: * Luminal A subtype of breast cancer. * Prior systemic therapy for breast cancer. * Serious comorbid conditions that would preclude study participation.
References
Publications (0)
Data not yet available