Clinical trial NCT01841749: Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraductal Carcinoma and Lobular Carcinoma in Situ
Keywords: Breast cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 231
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).

Eligibility 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

Primary outcomes:
measure: Highlight the contribution of sentinel node associated with a mastectomy immediately in pure ductal carcinoma in situ (DCIS) and micro-invasive (DCIS-MI)
timeFrame: 2 years
Secondary outcomes:
measure: Among women with ductal carcinoma in situ pure (DCIS) and micro-infiltrating (DCIS-MI) and indication of mastectomy
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: TUNON DE LARA Christine, MD
role: STUDY_CHAIR
References:
citation: Tunon-de-Lara C, Chauvet MP, Baranzelli MC, Baron M, Piquenot J, Le-Bouedec G, Penault-Llorca F, Garbay JR, Blanchot J, Mollard J, Maisongrosse V, Mathoulin-Pelissier 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.