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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraductal Carcinoma and Lobular Carcinoma in Situ

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery

sentinel node biopsy and mastectomy

Intervention Type PROCEDURE

sentinel node biopsy and mastectomy

Interventions

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sentinel node biopsy and mastectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No