CompletedNot Applicable

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

France228 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ

Timeframe: at surgery

Trial details

NCT IDNCT01841749

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-12

Results submitted2025-08-25

View on ClinicalTrials.gov More Intraductal Carcinoma and Lobular Carcinoma in Situ trials