Breast Cancer
Conditions
Interventions
experimental group:Carbon nanoparticles + tumor surface labeling
control group: tumor surface labeling
Sponsors
The Affiliated Yantai Yuhuangding Hospital of Qingdao University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-75 years old; 2. Those patients who were diagnosed with breast cancer by histopathology; 3. Patients with clinical stage IIa - IIIc had indications for neoadjuvant chemotherapy; 4. Patients with measurable primary breast lesions (according to RECIST v1.1); 5. ECoG PS: 0-1; 6. Those who were treated for the first time; 7. The patients whose laboratory examination met the following criteria: bone marrow function: absolute count of blood neutrophil (ANC) >= 1.5 x 10^9 / L; platelet (PLT) >= 100 x 10^9 / L; hemoglobin (HB) >= 90g / L; liver function: serum total bilirubin (STB), conjugated bilirubin (CB) = 60 ml / min (calculated by Cockcroft Gault formula); 8. Those who used contraception during the study and within six months after treatment; 9. Those who volunteered and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The patients with distant metastasis were found by auxiliary examination; 2. Patients with breast cancer during pregnancy and lactation; 3. Patients with severe cardiovascular diseases include uncontrolled hypertension (BP >= 160/95mmhg), unstable angina pectoris, history of myocardial infarction in the past 6 months, congestive heart failure > NYHA II, severe arrhythmia and pericardial effusion; 4. Patients with mental illness have poor compliance; 5. Sentinel lymph node biopsy was performed after chemotherapy in patients with clinical axillary negative or clinical axillary positive but no cancer metastasis; 6. The patients with multiple breast lesions can not be accurately located; 7. Patients with local skin ulceration or inflammatory breast cancer; 8. Patients with occult breast cancer; 9. Patients who can not be operated after neoadjuvant chemotherapy; 10. Patients allergic to nano carbon; 11. Those cases that the researchers considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diameter of carbon nanoparticles;Number of black stained lymph nodes;Pigmentation of skin;Granuloma formation at injection site;pCR;Negative rate of margin in breast conserving surgery; | — |
Countries
China
Contacts
Public ContactGuangdong Qiao
The Affiliated Yantai Yuhuangding Hospital of Qingdao University
Outcome results
None listed