Breast Cancer Invasive
Conditions
Keywords
breast cancer, Granzyme B, PET/CT, neoadjuvant treatment, pCR
Brief summary
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
DEVICE68Ga-GZMB PET/CT
68Ga-GZMB PET/CT
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXiaosong Chen
Backup ContactSiji Zhu
Outcome results
None listed