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

• 68Ga-GZMB PET/CT (Device): 68Ga-GZMB PET/CT

Primary outcomes

• Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR [through study completion, an average of 1 year]: Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer

Secondary outcomes

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

Sex: All, ages: 18 Years to 65 Years

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.

• Xiaosong Chen, Principal investigator, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital