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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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