Actively Recruiting
GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-12-10
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 to 65 years
- Histologically confirmed unilateral primary invasive breast cancer
- Tumor size 2 cm or larger with positive axillary lymph nodes, treated with neoadjuvant therapy
- Complete clinical and histopathological information available
- ECOG performance status of 0 or 1 within 10 days before study start
- Normal bone marrow reserve: white blood cell count ≥ 3.0×10^9/L, neutrophil count ≥ 1.5×10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 80×10^9/L
- Normal liver and kidney function: AST ≤ 2.5 times upper normal limit, total bilirubin ≤ 1.5 times upper normal limit, serum creatinine ≤ 1.5 times upper normal limit, creatinine clearance > 50 ml/min
- Good compliance with planned treatment, understands research procedures, and signed informed consent
You will not qualify if you...
- Bilateral or metastatic (stage IV) breast cancer
- History of other malignancies in past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infection or uncontrolled diseases
- Psychiatric disorders or inability to comply with treatment
- Known allergy or intolerance to study drug or excipients
- Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason
- Pregnant, lactating, or reproductive-age patients refusing contraception during study
- Deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
Research Team
X
Xiaosong Chen
CONTACT
S
Siji Zhu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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