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

Not Applicable

Completed

• Conditions: Intraductal Carcinoma and Lobular Carcinoma in Situ
• Interventions: Procedure: sentinel node biopsy and mastectomy

• Registration Number: NCT01841749
• Lead Sponsor: Institut Bergonié

Brief Summary

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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 231

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	sentinel node biopsy and mastectomy	sentinel node biopsy and mastectomy

Primary Outcome Measures

Name	Time	Method
Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI)	2 years	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

Name	Time	Method
Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy	2 years	* 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

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, Aquitaine, France