Breast cancer
Conditions
Interventions
Case series:Place a clip in the positive lymph node (single) that has been punctured in the armpit before chemotherapy
Sponsors
He'nan Breast Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 70 years old; 2. ECOG score 0~1 points; 3. Pathologically diagnosed as a patient with invasive breast cancer, the tumor stage is early (T1-3, N1, M0); Note: Our definition of c N1 in this study: (1) The metastasis must be confirmed pathologically, and patients with lymph node metastasis in the superior and inferior clavicle area must be excluded; (2) The clinical examination can be mobile, excluding fusion-fixed ones; (3) Color Doppler ultrasound combined with enhanced CT, >=4 suspected positive lymph nodes also need to be excluded; (4) The short diameter of lymph nodes >=20mm also needs to be excluded; 4. The main organs are functioning normally, that is, they meet the following standards: Routine blood examination standards should meet: ANC >=1.5x10^9/L; PLT >=90x10^9/L; Hb >=90g/L; The biochemical examination must meet the following standards: TBIL=50 mL/min (CockcroftGault formula); Heart color Doppler ultrasound and echocardiography: left ventricular ejection fraction (LVEF>=55%); 5. Complete the established neoadjuvant chemotherapy program; 6. After completion of neoadjuvant chemotherapy and preoperative imaging assessment is axillary cN0 Note: Our definition of c N0 after neoadjuvant in this study: imaging examination showed that the short diameter of axillary lymph nodes <=10mm, and imaging examination did not indicate metastatic lymph nodes, and the examination did not touch swollen lymph nodes; 7. For female patients who have not undergone menopause or have not undergone surgical sterilization: during the treatment period and at least 7 months after the last dose in the study treatment, agree to abstain from sex or use an effective method of contraception; 8. Volunteer to join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. T4, N2-3 and IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Past received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4. The patient has undergone axillary surgery in the past; 5. Patients with severe cardio-cerebrovascular, liver, kidney and other primary diseases who cannot tolerate surgery 6. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 7. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and 7 months after the last study medication; 9. Have bleeding tendency, blood coagulation mechanism disorder, etc. (platelets =1.5, PT>=18s or APTT>=60s); 10. Suffer from serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, or any other situation where the investigator believes that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TAD detection rate;TAD false negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-TAD lymph node involvement rate;TAD failure rate;Clip-labeled lymph node detection rate;Safety index; | — |
Countries
China
Contacts
Public ContactXiuchun Chen
Department of Breast disease, He'nan Breast Cancer Center
Outcome results
None listed