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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT01841749
First received: November 5, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

The rate of axillary dissection avoided in patients with Ductal Carcinoma in Situ (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. A confidence interval of 95% will be deferred.


Condition Intervention
Intraductal Carcinoma and Lobular Carcinoma in Situ
Procedure: sentinel node biopsy and mastectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Highlight the interest of GAS associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-infiltrating (DCIS-MI) with indication of mastectomy in estimating the rate of axillary dissection avoided due a GAS-detected


Secondary Outcome Measures:
  • Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • Number and rate of axillary dissection performed immediately during the mastectomy following the discovery of a GAS +, having avoided a surgical procedure later;
    • rate of discordance between biopsy and histology final;
    • detection rate of sentinel axillary lymph nodes (GAS), regardless of nodal status;
    • GAS positive rate in the population of patients in whom the GAS has been detected.

      200 patients: 100 patients with a biopsy showing DCIS and an indication of mastectomy and 100 patients with a biopsy showing DCIS-MI and an indication of mastectomy



Enrollment: 231
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgery
sentinel node biopsy and mastectomy
Procedure: sentinel node biopsy and mastectomy
sentinel node biopsy and mastectomy

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841749

Locations
France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: TUNON DE LARA Christine, MD Institut Bergonié
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01841749     History of Changes
Other Study ID Numbers: IB2007-40
Study First Received: November 5, 2012
Last Updated: April 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Breast cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014