Clinical trial · Observational
Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC
Study of the Features of Senescent T Lymphocytes Induced by Chemotherapy and Its Relationship with the Efficacy of Neoadjuvant Chemotherapy in Young Triple-negative Breast Cancer Patients, a Single-center, Observational Study.
- 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)
The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients. The main questions it aims to answer are: * What are the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy? * What is the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes? 1. Participants will receive 6 cycles of docetaxel + adriamycin/epirubicin + cyclophosphamide (TEC/TAC) neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. 2.5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. 3.Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Events | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| T-Cell Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel, anthracycline, cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NAC group
- description
- Participants will receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study. 5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery.
- interventionNames
- Drug: docetaxel, anthracycline, cyclophosphamide
Primary outcomes (1)
- measure
- pCR
- timeFrame
- 2024/7-2027/6
- description
- pathological complete response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, age≤40 years old, 2. Invasive breast cancer confirmed by pathology, immunohistochemistry showed TNBC (ER-, PR-, HER2-), 3. Indications for neoadjuvant chemotherapy according to guidelines: tumor diameter \> 2cm or with axillary lymph node metastasis or desiring breast-conserving surgery but should obtain negative surgical margins through neoadjuvant chemotherapy. Exclusion Criteria: 1. Stage IV patients or a history of other malignancies, 2. Having microbial infection or autoimmune disease have not been cured or having HBV, HIV infection, 3. Having surgery 3 months before enrollment, 4. Patients with insufficient clinicopathological data, 5. Does not meet the indications for neoadjuvant chemotherapy or is unwilling to cooperate.
References
Publications (0)
Data not yet available