Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The enrolled patients will receive neoadjuvant chemotherapy. After neoadjuvant chemotherapy and before radical axillary lymph node dissection, sentinel lymph node tracer will be injected. Before routi
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| False negative rate of sentinel lymph node biopsy at postoperative day one, according to pathological results and referencing to gold standard, false negative rate of sentinel lymph nodes = (number of patients having false negative sentinel lymph nodes/number of patients having gold standard results) ×100% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At postoperative day one, the relationship between each influential factor (neoadjuvant efficacy, tumor location, surgical procedure, number of sentinel lymph nodes detected, molecular subtypes of breast cancer (luminal A, luminal B, HER2-positive, triple-negative)) and the results of sentinel lymph node biopsy after neoadjuvant chemotherapy 2. Adverse events during the trial | — |
Countries
China
Contacts
Public ContactBo Chen
Outcome results
None listed