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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

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).

Interventions

  • Procedure: sentinel node biopsy and mastectomy
    • sentinel node biopsy and mastectomy

Arms, Groups and Cohorts

  • Other: Surgery
    • sentinel node biopsy and mastectomy

Clinical Trial Outcome Measures

Primary 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
    • 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 Measures

  • Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy
    • Time Frame: 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

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Institut Bergonié
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • TUNON DE LARA Christine, MD, Study Chair, Institut Bergonié

    Citations Reporting on Results

    Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouédec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pélissier S, MacGrogan G. The Role of Sentinel Lymph Node Biopsy and Factors Associated with Invasion in Extensive DCIS of the Breast Treated by Mastectomy: The Cinnamome Prospective Multicenter Study. Ann Surg Oncol. 2015 Nov;22(12):3853-60. doi: 10.1245/s10434-015-4476-5. Epub 2015 Mar 17.

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