Clinical trial · Observational
TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients
Do Tumor-Infiltrating Lymphocytes Predict Complete Pathologic Response to Neoadjuvant Systemic Therapy in Breast Cancer Patients?
- 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)
Neoadjuvant systemic treatment for breast cancer (used in locally advanced and operable breast cancer) includes anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients. The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).
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 |
|---|---|---|---|
| TIL assessment in pre-existing histopathological specimens | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TIL in breast cancer patients who completed neoadjuvant therapy
- description
- * Tumour infiltrating lymphocytes will be examined on pre-existing histopathologic samples. * Data will be extracted from the files of the patients including: * Demographic data, clinicopathologic data, pathologic complete response, and date of last follow up.
- interventionNames
- Diagnostic Test: TIL assessment in pre-existing histopathological specimens
Primary outcomes (1)
- measure
- Assessment of TIL relation to pathologic complete response
- timeFrame
- 1 year
- description
- TIL examined from pre-existing histopathological specimens and data of pathologic complete response will be collected from medical records
Secondary outcomes (1)
- measure
- 1-year disease-free interval
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years old or more * Histologically proven invasive breast cancer * All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer * Patients who completed their systemic neoadjuvant therapy Exclusion Criteria: * Second malignancy * Patients who started but didn't complete neoadjuvant systemic therapy * Patients who didn't undergo surgery after neoadjuvant systemic therapy * Pregnant patients
References
Publications (0)
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