Intraductal Carcinoma and Lobular Carcinoma in Situ
Conditions
Keywords
Breast cancer
Brief summary
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients.
Interventions
PROCEDUREsentinel node biopsy and mastectomy
sentinel node biopsy and mastectomy
Sponsors
Institut Bergonié
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ | at surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy | at surgery | Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgery sentinel node biopsy and mastectomy | 228 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Surgery | — |
|---|---|---|
| Age, Continuous | 52 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 228 participants | — |
| Sex: Female, Male Female | 228 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
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).
Time frame: at surgery
Population: Women with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgery | Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ | 51 Participants |
Secondary
Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy
Numerator : number of patients with discordant results between VAB and mastectomy Denominator : total number of patients
Time frame: at surgery
Population: Women with vacuum-assisted biopsy (VAB) diasgnosis available and mastectomy diagnosis available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgery | Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy | 76 Participants |