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GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer

GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer

Recruiting
18-65 years
All
Phase N/A

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Overview

To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.

Eligibility

Inclusion Criteria:

  • age 16-65
  • histologically confirmed unilateral primary invasive breast cancer
  • Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy
  • complete clinical and histo-pathological information
  • ECOG 0-1 within 10 days from the beginning of the study
  • Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10^9/L, Neutrophil count ≥ 1.5×10^9/L, Hemoglobin level ≥ 90g/L; Platelet count (PLT) ≥ 80×10^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate > 50ml/min.
  • The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form

Exclusion Criteria:

  • bilateral or metastatic (stage IV) breast cancer
  • There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
  • Severe systemic infection or other uncontrolled diseases
  • Patients with psychiatric disorders or those unable to comply with treatment due to other reasons
  • Known allergy or intolerance to the drug or its excipients
  • Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past
  • Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.
  • Patients deemed unsuitable for participation in this study by the investigator.

Study details
    Breast Cancer Invasive

NCT06725940

Shanghai Jiao Tong University School of Medicine

15 October 2025

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