RecruitingNCT06518135

Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer

Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study


Sponsor

Henan Cancer Hospital

Enrollment

508 participants

Start Date

Apr 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a less invasive approach to checking underarm (axillary) lymph nodes in people with early breast cancer who received chemotherapy before surgery. Rather than removing many lymph nodes, researchers are testing whether a targeted sentinel lymph node biopsy (removing only the key "sentinel" nodes) is accurate after chemotherapy has shrunk the cancer. **You may be eligible if...** - You are a patient with stage cT1–T3, N1, M0 breast cancer (cancer spread to 1–3 underarm lymph nodes, but not distant organs), confirmed by imaging - You had no more than 3 abnormal lymph nodes detected by imaging before treatment - You responded well to neoadjuvant (pre-surgery) chemotherapy (tumor showed complete or partial response) - Your performance status is good (ECOG 0–1) **You may NOT be eligible if...** - Your lymph node involvement was more extensive (more than 3 nodes) - You did not respond to pre-surgery chemotherapy - You have inflammatory breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSLNB group

After the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative.


Locations(1)

Henan cacer hospital

Henan, Henan, China

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NCT06518135


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