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NCT06448169

Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer

Sponsor: Shandong University

View on ClinicalTrials.gov

Summary

Studies have reported that tumors with the same immunogenic mutations may induce T cell receptor (TCR) domains with similar antigen recognition functions. By assembling the complementarity-determining region 3 (CDR3) of TCRs from RNA-seq data and correlating them with 9142 samples from TCGA data, an in-depth analysis of the TCR pool in the tumor microenvironment found a strong correlation between the CDR3 sequences of tumor-infiltrating T cells and tumor mutation burden. Fairfax et al. found that in patients responding to tumor immunotherapy, the TCR immune pool of CD8+ T cells produces many clones with extremely high abundance (exceeding 0.5%) . Cader et al. also found significant changes in the TCR immune pool of patients with Hodgkin's lymphoma responding to PD-1 tumor immunotherapy. Based on these theoretical foundations, evaluating the dynamic changes of the TCR immune pool is expected to be used to analyze the immune characteristics and changes in diseases such as malignant tumors.

Official title: Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer Based on High-Resolution Dynamic Immune Signature Analysis

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-05-30

Completion Date

2026-04-30

Last Updated

2024-06-07

Healthy Volunteers

Conditions

Triple Negative Breast Cancer Neoadjuvant Immunotherapy Sensitivity

Interventions

DRUG

PD-1 inhibitor

PD-1 inhibitor combined with neoadjuvant chemotherapy

Inclusion Criteria: 1. Age: 18-60 years old; 2. Histologically confirmed triple-negative breast cancer, with immunohistochemistry showing ER \<1%, PR \<1%, HER2-negative (IHC 0 or 1+; or IHC 2+ ISH-negative); 3. Imaging-confirmed non-metastatic disease; 4. Clinical efficacy can be evaluated according to RECIST criteria; 5. European Functional Handicap Scale (MRC) of 0-2; 6. The investigator determines that the treatment is tolerable based on the patient's organ function level; 7. Volunteers willing to participate in this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up. Exclusion Criteria: 1. Immunohistochemistry showing HER2-positive (IHC 3 or IHC 2 ISH-amplified); 2. Previously treated; 3. Severe dysfunction of important organs such as heart, liver, and kidneys; 4. Patients with diseases unsuitable for immunotherapy; 5. Known allergy history to any component of the drugs in this regimen; 6. History of immune deficiency, including HIV-positive, HCV, active hepatitis B, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 7. Any cardiac disease, including: ① Medically treated or clinically significant arrhythmias; ② Myocardial infarction; ③ Heart failure; ④ Any other cardiac disease judged by the investigator as unsuitable for participation in this trial; 8. Pregnant or lactating women, fertile women with positive baseline pregnancy test or those unwilling to take effective contraceptive measures during the entire trial; 9. According to the investigator's judgment, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension uncontrollable by drugs, severe diabetes, active infections, etc.); 10. Long-term use of drugs that affect the components of peripheral blood immune cells, such as recombinant human erythropoietin, recombinant human granulocyte colony-stimulating factor, recombinant human interleukin, or Likejun tablets; 11. Received immunosuppressive therapy within 2 weeks; 12. Hematological precancerous diseases, such as myelodysplastic syndrome, and coagulation disorders.