Clinical trial NCT04482803: Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN+ Breast Cancer
Official title: Feasibility Study of Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node After Neoadjuvant Systemic Therapy for Clinically Assessed Positive Axillary Lymph Node (cN+) Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Location and Biopsy of Axillary Lymph Nodes
Keywords: Breast cancer
neoadjuvant chemotherapy
Axillary lymph nodes positive
Carbon-tattooed Lymph Nodes
locating clip
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after neoadjuvant systemic therapy for cN+ breast cancer, and evaluate whether it can accurately predict axillary lymph node status after neoadjuvant systemic therapy.

Detailed description: Locally advanced breast cancer patients with clinical assessed positive axillary lymph node (cN+) who receive neoadjuvant systemic therapy (NST) will be enrolled in this study. Before NST, one of the suspected lymph nodes will be subjected to ultrasound-guided core needle biopsy (CNB) or fine needle aspiration (FNA), and a locating clip will be placed. Meanwhile, a small amount of Kanarine (Carbon Nanoparticles Suspension Injection) will be injected into or around the cortex of the locating lymph node as well as other positive lymph nodes. All patients will be confirmed to have axillary lymph node metastasis by pathologic or cytologic examination. After NST, FNA will be performed again for the lymph nodes labelled with previous locating clip. During the operation, the clip labelled lymph nodes were identified with carbon and sent to pathology separately. Meanwhile, the remaining carbon labelled lymph nodes were also separately examined. Axillary lymph node dissection will be performed in all patients. The detection rate of labelled lymph node will be record, and the pathological results of re-FNA of labelled lymph nodes will be compared with postoperative pathological results. Meanwhile, we will also analysis whether carbon labelled lymph node biopsy could predict the overall status of axillary lymph nodes after NST.

Eligibility criteria: Inclusion Criteria:

1. Female breast cancer patients who received neoadjuvant systemic chemotherapy, aged 18-70 years old, with clinically assessed positive lymph node, and the expected survival period is greater than 12 months.
2. No previous radiotherapy and chemotherapy.
3. No history of serious systemic disease.
4. KPS≥70.
5. White blood cell count\> 3.5 × 10 \^ 9 / L, neutrophil count\> 1.8 × 10 \^ 9 / L, platelet count\> 100 × 10 \^ 9 / L, hemoglobin\> 9 g / dl.
6. ALT and AST \<1.5 times the upper limit of normal value, alkaline phosphatase \<2.5 times the upper limit of normal value, and total bilirubin \<1.5 times the upper limit of normal value.
7. Serum muscle plasma \<1.5 times the upper limit of normal value.
8. No abnormal blood coagulation.
9. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
10. Cardiac function: two-dimensional echocardiography examination LVEF ≥ 55%.
11. Sign informed consent.

Exclusion critia:

1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy and endocrine therapy.
2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
3. The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression and other diseases, can not tolerate chemotherapy related treatments.
5. Two-dimensional echocardiography detection LVEF \<55%.
6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension\> 150/90 mmHg, myocardial infarction or cerebrovascular accident).
7. NCI peripheral neurotoxicity grade ≥2.
8. Those taking glucocorticoids.
9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab or pertuzumab.
10. Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
11. Pregnant and lactating women.
12. After joining the test, a pregnancy test (+) before using the drug.
13. There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan and follow-up workers (systematic evaluation is required before the trial is enrolled).
14. No personal freedom and independent civil capacity.
15. The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Primary outcomes:
measure: The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes
timeFrame: 1-3 day before NST, the suspected lymph nodes will be injected carbon nanoparticle. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination.
Secondary outcomes:
measure: The consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.
timeFrame: 1-3 day before NST, one of the cN+ nodes will be placed a locating clip. 1-3 days before surgery, the clip labeled node will be punctured again. During operation, the clip labeled node will be identified and sent for examination.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaoming Zha, Doctor
role: STUDY_DIRECTOR
References: