Evaluating Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients

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

This study is trying to see if a specific type of lymph node surgery is safe and effective for breast cancer patients who have had chemotherapy and show no signs of cancer in their lymph nodes.

Quick facts

• Study type: Observational
• Enrollment: 508 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: Radiation
• Locations: 1 site (Henan, Henan)
• Trial ID: NCT06518135 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the optimal technical pathway and long-term tumor safety of axillary sentinel lymph node biopsy (SLNB) in patients with initial cN1 breast cancer who have undergone neoadjuvant chemotherapy and have downgraded to ycN0. The study will focus on evaluating axillary recurrence-free survival as the primary endpoint, while secondary endpoints include regional lymph node recurrence-free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life. By analyzing real-world data, the study seeks to clarify the best practices for SLNB in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with stage cT1-3N1M0 breast cancer who have received effective neoadjuvant therapy and have clinical axillary negative ycN0 status.

Not a fit: Patients with prior history of ipsilateral axillary surgery or radiation therapy, or those with other malignant tumors within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines for the safe and effective use of SLNB in breast cancer patients, potentially improving patient outcomes.

How similar studies have performed: Other studies have explored sentinel lymph node biopsy techniques, but this specific approach in the context of neoadjuvant chemotherapy and axillary downgrading is less established.

Eligibility criteria

Inclusion Criteria:

1. Patients With ECOG Score 0-1 Points
2. Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
3. Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
4. Patients With Effective Neoadjuvant Therapy (CR+PR)
5. Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
6. Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
7. Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
8. Patients Without Obvious Contraindications for Surgery or Radiation Therapy
9. No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
10. Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally
11. The patient voluntarily joined this study and signed an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer；
2. Simultaneous double breast cancer；
3. Baseline cT4;
4. Baseline cN2-3
5. gestation
6. There are contraindications for SLNB;
7. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study

Where this trial is running

Henan, Henan

• Henan cacer hospital — Henan, Henan, China (Recruiting)

Study contacts

• Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu

Conditions Sentinel Lymph Node Biopsy; Axillary sentinel lymph node biopsy