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

Official title

Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe

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.

Interventions

• Device 68Ga-GZMB PET/CT
  68Ga-GZMB PET/CT

Primary outcome measures

• Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR [Time frame: through study completion, an average of 1 year]

Secondary outcome measures (3)

• Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR [Time frame: through study completion, an average of 1 year]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT [Time frame: through study completion, an average of 1 year]
• Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Shanghai

Identifiers

NCT: NCT06725940 · RJBC-GZMB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗