Trial Outcomes & Findings for Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast (NCT NCT01841749)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

228 participants

Primary outcome timeframe

at surgery

Results posted on

2025-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Surgery sentinel node biopsy and mastectomy
Overall Study STARTED	228
Overall Study COMPLETED	227
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgery sentinel node biopsy and mastectomy
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery n=228 Participants sentinel node biopsy and mastectomy
Age, Continuous	52 years n=228 Participants
Sex: Female, Male Female	228 Participants n=228 Participants
Sex: Female, Male Male	0 Participants n=228 Participants
Region of Enrollment France	228 participants n=228 Participants

PRIMARY outcome

Timeframe: at surgery

Population: Women with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).

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).

Outcome measures

Outcome measures
Measure	Surgery n=76 Participants sentinel node biopsy and mastectomy sentinel node biopsy and mastectomy: sentinel node biopsy and mastectomy
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ	51 Participants

SECONDARY outcome

Timeframe: at surgery

Population: Women with vacuum-assisted biopsy (VAB) diasgnosis available and mastectomy diagnosis available

Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients

Outcome measures

Outcome measures
Measure	Surgery n=196 Participants sentinel node biopsy and mastectomy sentinel node biopsy and mastectomy: sentinel node biopsy and mastectomy
Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy	76 Participants

Adverse Events

Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place