Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemo… (NCT07032220) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study
China175 participantsStarted 2024-12-09
Plain-language summary
In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. women aged 18-70 years
. The primary breast lesion was confirmed as invasive breast cancer by core needle biopsy
. Axillary lymph node metastasis confirmed by fine needle aspiration or core needle biopsy
. plan to undergo neoadjuvant chemotherapy
. operable breast cancer
. Patients with good heart, lung, liver, and kidney function are suitable for surgery
. Informed consent
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated.
. previous ipsilateral axillary surgery or radiotherapy
. Due to personal or family factors, the patient is unable to cooperate with the surgical treatment recommended by the doctor according to the condition (breast conserving surgery or radical surgery).
. Patients with severe heart and lung diseases, uncontrolled infectious diseases and other non-tumor related diseases could not tolerate comprehensive treatment such as surgery and chemotherapy
. Unable to sign the informed consent form due to mental illness or other reasons
. Poor medical compliance, and the study group believed that the patients could not complete the trial treatment process and follow-up according to the standard