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

Institut Bergonié228 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

228

Conditions

Intraductal Carcinoma and Lobular Carcinoma in Situ

Interventions

sentinel node biopsy and mastectomyPROCEDURE

sentinel node biopsy and mastectomy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Bergonié

Bordeaux, Aquitaine, France

Outcomes

Primary Outcomes

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

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).

Time frame: at surgery

Secondary Outcomes

Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy

Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients

Time frame: at surgery

Data from ClinicalTrials.gov

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