Adverse Events, Chemotherapy Effect, T-Cell Dysfunction
Conditions
Keywords
breast cancer, senescence, chemotherapy
Brief summary
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.
Detailed description
This is a single-center observational study that is expected to enroll 30 breast cancer patients and 10 controls from July 2023 to June 2026. We mainly want to investigated senescent T lymphocytes characteristics during neoadjuvant chemotherapy in young triple-negative breast cancer patients. Besides, the relationship between senescent T lymphocytes and neoadjuvant chemotherapy efficacy also of concern to us. Inclusion criteria: (1) female, age ≤40 years old; (2) Invasive breast cancer was confirmed by puncture pathology and TNBC (ER-, PR-, HER2-) was confirmed by immunohistochemistry; (3) Patients who meet the indications of neoadjuvant chemotherapy prescribed in the guidelines. Exclusion criteria: (1) IV patient or history of other malignant tumors; (2) Recently infection or autoimmune disease is not cured or HBV, HIV positive; (3) Had a history of surgery 3 months before enrollment; (4) Patients with insufficient clinicopathological data; (5) Those who do not meet the evidence of neoadjuvant chemotherapy or are unwilling to cooperate. Withdrawal criteria: (1) the subjects did not receive radical surgery in our hospital or were unwilling to continue to participate in the follow-up study; (2) Termination of chemotherapy due to serious side effects or disease progression during chemotherapy; (3) Research data related to the experiment is missing and cannot be supplemented; (4) Poor specimen quality (hemolysis, contamination, etc.); (5) Follow-up lost. 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. The senescence phenotype of T lymphocytes will be determined by flow cytometry. The main purpose are: * Studying the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy. * Studying the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes.
Interventions
1. Participants were required to receive 6 cycles of TEC/TAC neoadjuvant chemotherapy, and radical mastectomy was required after chemotherapy. 2. 5ml peripheral venous blood was 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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | 2024/7-2027/6 | pathological complete response |