๐ฌIn 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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* age 16-65
* histologically confirmed unilateral primary invasive breast cancer
* Tumor sizeโฅ2cm, 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 โฅ 3.0ร10\^9/L, Neutrophil count โฅ 1.5ร10\^9/L, Hemoglobin level โฅ 90g/L; Platelet count (PLT) โฅ 80ร10\^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) โค 2.5 times the upper limit of normal, Total bilirubin โค 1.5 times the upper limit of normal, Serum creatinine โค 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.