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โ† Trials
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GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer

Recruitingn/aAges 18 Years - 65 YearsAllShanghai Jiao Tong University School of Medicine
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * age 16-65 * histologically confirmed unilateral primary invasive breast cancer * Tumor sizeโ‰ฅ2cm, 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 โ‰ฅ 3.0ร—10\^9/L, Neutrophil count โ‰ฅ 1.5ร—10\^9/L, Hemoglobin level โ‰ฅ 90g/L; Platelet count (PLT) โ‰ฅ 80ร—10\^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) โ‰ค 2.5 times the upper limit of normal, Total bilirubin โ‰ค 1.5 times the upper limit of normal, Serum creatinine โ‰ค 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.
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What it tests

  • 68Ga-GZMB PET/CT
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Where

1 site
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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