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

NCT06518135 | Recruiting

• 1 other identifier: 2024-157
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node Biopsy

Keywords

Axillary sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• Axillary recurrence-free survival

  The time from surgery to axillary recurrence or last follow-up

  5th year after surgery

Secondary Outcomes (5)

• regional lymph node recurrence-free survival

  5th year after surgery

• Disease-free survival

  5th year after surgery

• Overall survival

  5th year after surgery

• The incidence of postoperative upper limb lymphedema

  5th year after surgery

• EORTC-QLQ-C30 V3 rating

  5th year after surgery

Study Arms (1)

SLNB group

Standard sentinel lymph node biopsy group, if frozen pathology SLNs are negative, no ALND will be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If the frozen pathology is false negative, it is recommended to complete ALND within 12 weeks after SLNB surgery.

Other: SLNB group

Interventions

SLNB group OTHER

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.

Also known as: experimental group

SLNB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes

You may qualify if:

• Patients With ECOG Score 0-1 Points
• 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
• Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
• Patients With Effective Neoadjuvant Therapy (CR+PR)
• Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
• Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
• Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
• Patients Without Obvious Contraindications for Surgery or Radiation Therapy
• No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
• 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
• The patient voluntarily joined this study and signed an informed consent form.

You may not qualify if:

• Stage IV (metastatic) breast cancer；
• Simultaneous double breast cancer；
• Baseline cT4;
• Baseline cN2-3
• gestation
• There are contraindications for SLNB;
• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cacer hospital

Henan, Henan, 450008, China

RECRUITING

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu

CONTACT

0371-65587005; liuzhenzhen73@126.com

Minhao Lv

CONTACT

0371-65587406

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 17, 2024

Record last verified: 2024-05

Locations

CN (1)