Feasibility of sentinel lymph node biopsy using dye alone method in Chinese patients with cN1 breast cancer after neoadjuvant chemotherapy evaluated by clinical physical examination and three-dimensional ultrasound: a prospective, multicenter, diagnostic trial

The First Hospital of China Medical University0 个研究点目标入组 500 人开始时间: 2019年10月29日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1. Women, age at 18-70 years
•2. Primary invasive breast adenocarcinoma confirmed by physical examination, breast color Doppler ultrasound, mammography, MRI evaluation, and hollow needle histological examination. Before treatment, all patients have cN1 lymph nodes, i.e., subaxillary enlarged lymph nodes palpable by clinical examination and/or suspected positive enlarged lymph nodes revealed by related examinations, which are not considered as metastatic lymph nodes;
•3. Not previously received treatment for breast cancer, agree to participate in the study, and have good compliance
•4. The Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
•5. Before treatment, the results of hematological and biochemical examinations should meet the following conditions: white blood cells = 4.0 x 109/L, absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, hemoglobin = 90 g/L, glutathione transaminase, alanine transaminase = 1.5 x upper limit of normal, creatinine = 1.5 x upper limit of normal, total bilirubin = 1.5 x upper limit of normal
•6. No serious heart, liver and kidney diseases

•1. No provision of written informed consent
•2. Lactating or pregnant women
•3. Confirmed distant metastasis of breast cancer
•4. Sensory or motor neuropathy, or those diagnosed with psychiatric disorder
•5. Confirmed cardiovascular diseases, serious concomitant diseases or active infections including known human immunodeficiency virus infection
•6. History of other cancers
•7. Allergic to drugs and excipients involved in tracers and neoadjuvant chemotherapy

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