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

September 11, 2025 updated by: Institut Bergonié

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The rate of axillary dissection avoided in patients with DCIS and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI (after the final histology). A confidence interval of 95% will be deferred (binomial).

The rate of axillary dissection avoided in patients with DCIS-MI and an indication of mastectomy is obtained by calculating the proportion of women with a GAS-all women with DCIS-MI and an indication of mastectomy. A confidence interval of 95% will be deferred (binomial).

Study Type

Observational

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were recruited from 14 participating French comprehensive cancer centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery
sentinel node biopsy and mastectomy
Procedure: sentinel node biopsy and mastectomy
sentinel node biopsy and mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Study Chair: TUNON DE LARA Christine, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimated)

April 26, 2013

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2007-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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