Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

Completed

• Conditions: Ductal Carcinoma in Situ
• Interventions: Procedure: Mastectomy with sentinel lymph node biopsy

• Registration Number: NCT05961280
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 385

Inclusion Criteria

1. Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy
2. Women underwent curative surgery for DCIS

Exclusion Criteria

1. Patients who received breast-conserving surgery
2. Patients who had concurrent contralateral invasive breast cancer
3. Patients who were in case of ipsilateral breast tumor recurrence
4. Patients whose invasiveness was uncertain in the biopsy samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DCIS Mastectomy	Mastectomy with sentinel lymph node biopsy	Patients who undergo mastectomy with sentinel lymph node biopsy for DCIS at biopsy

Primary Outcome Measures

Name	Time	Method
Axillary lymph node metastasis rate	up to 2 weeks after surgery	Our primary objective was to identify the axillary lymph node metastasis rate in patients with DCIS at diagnosis who underwent mastectomy with axillary surgery.