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

Institut Bergonié

Status: Completed

Conditions: Intraductal Carcinoma and Lobular Carcinoma in Situ

Treatments: Procedure: sentinel node biopsy and mastectomy

Study type: Observational

Funder types: Other

Identifiers

NCT01841749

IB2007-40

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

228 participants in 1 patient group

Surgery

Description:

sentinel node biopsy and mastectomy

Treatment:

Procedure: sentinel node biopsy and mastectomy