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

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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Key information

Conditions

Intraductal Carcinoma and Lobular Carcinoma in Situ Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sentinel node biopsy and mastectomy

Procedure

sentinel node biopsy and mastectomy

Primary outcomes

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

Time frame: at surgery
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

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

Time frame: at surgery

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

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: CINNAMOME

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Apr 26, 2013
Registry last updated: Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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