Clinical trial · Observational
Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast
Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Carcinoma and Lobular Carcinoma in Situ | Breast Ductal Carcinoma In Situ and Lobular Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sentinel node biopsy and mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Surgery
- description
- sentinel node biopsy and mastectomy
- interventionNames
- Procedure: sentinel node biopsy and mastectomy
Primary outcomes (1)
- measure
- Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
- timeFrame
- at surgery
- description
- 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 outcomes (1)
- measure
- Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouedec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pelissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invasion in Extensive DCIS of the Breast Treated by Mastectomy: The Cinnamome Prospective Multicenter Study. Ann Surg Oncol. 2015 Nov;22(12):3853-60. doi: 10.1245/s10434-015-4476-5. Epub 2015 Mar 17. PMID 25777085