Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast

Not Applicable

Completed

• Conditions: Intraductal Carcinoma and Lobular Carcinoma in Situ

• Registration Number: NCT01841749
• Lead Sponsor: Institut Bergonié

Brief Summary

When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients.

Detailed Description

The rate of axillary dissection avoided in patients with DCIS and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI (after the final histology). A confidence interval of 95% will be deferred (binomial).

The rate of axillary dissection avoided in patients with DCIS-MI and an indication of mastectomy is obtained by calculating the proportion of women with a GAS-all women with DCIS-MI and an indication of mastectomy. A confidence interval of 95% will be deferred (binomial).

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2010-12
• Study Completion: 2010-12-01
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Results First Submitted: 2025-08-25
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Results First Posted: 2025-09-12
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

• Older than 18 years.
• Preoperative histological diagnosis obtained by biopsy
• Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI)
• Indication of mastectomy
• Patient signed informed consent

Exclusion Criteria

• Age < 18 years
• Infiltrating ductal carcinoma (TCC) diagnosed on biopsy
• Pure DCIS diagnosed by lumpectomy
• DCIS can take a conservative treatment
• Mastectomy chosen by the patient
• History of breast carcinoma in situ or invasive ipsilateral
• Prior radiotherapy to the ipsilateral breast
• History of axillary lateral homo
• Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study
• Patient deprived of liberty or under guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ	at surgery	Women who benefited of performing upfront sentinel lymph node (SLN) biopsy are women for whom unecessary axillary lymph node dissection (ALND) was avoided.; The proportion of women who benefited of performing upfront sentinel lymph node (SLN) biopsy is calculated as : * numerator : number of patients with negative SLNs; * denominator : total number of patients with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).

Secondary Outcome Measures

Name	Time	Method
Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy	at surgery	Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, Aquitaine, France