Breast cancer
Conditions
Interventions
Case series:None
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 or older and less than or equal to 70 years old; 2. All patients were pathohistologically confirmed as breast cancer; 3. In early breast cancer, there is no distant metastasis, no lymph node metastasis confirmed by pathology, no clinically palpated enlarged lymph nodes, and no enlarged lymph nodes indicated by ultrasound or magnetic resonance; 4. KPS score =70 points; 5. The functional level of organs is basically normal: bone marrow function, liver and kidney function, heart; 6. Volunteer to participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up; 7. Using methylene blue for sentinel lymph node biopsy, blue-stained sentinel lymph nodes were found and sent for testing, revealing cancer metastasis.
Exclusion criteria
Exclusion criteria: 1. Received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) before surgery; 2. Accept any other anti-tumor treatment at the same time; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Stage IV breast cancer; 5. Other malignant tumors have occurred in the past 5 years, except for cured cervical carcinoma in situ; 6. Those with severe functional insufficiency of vital organs such as the heart, liver, and kidneys; 7. Those with known allergy history to methylene blue components in this protocol; 8. Any previous heart disease, including: (1) arrhythmia requiring medication or having clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease judged by the investigator as being unsuitable for participation in this trial; 9. Pregnant and lactating women; 10. The biopsy method of sentinel lymph nodes is radionuclide; 11. No blue staining was observed in sentinel lymph nodes; 12. No cancer metastasis in sentinel lymph nodes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| False negative rate of sentinel lymph node biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive rate of lymph nodes in the blue dye sentinel node;Positive rate of non-blue staining sentinel lymph nodes;Positive rate of non-sentinel lymph nodes;Negative rate of non-blue-stained sentinel lymph nodes; | — |
Countries
China
Contacts
Public ContactZhi Xiao
Xiangya Hospital, Central South University
Outcome results
None listed