N/A
N=228
Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast
Intraductal Carcinoma and Lobular Carcinoma in Situ
Bottom Line
View on ClinicalTrials.gov: NCT01841749 ↗Enrolled (actual)
228
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ — 51 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sentinel node biopsy and mastectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Institut Bergonié
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ |
51 | — |
| SECONDARY Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy |
76 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01841749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.