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

Recruiting

• Conditions: Breast Cancer Invasive

• Registration Number: NCT06725940
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital; 🇨🇳 Shanghai, China