NCT02908178

Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

Completed Results posted Last updated 15 May 2019

What this trial tests

trial testing Sentinel lymph node biopsy (SLNB) in Ductal Carcinoma In Situ in 28,291 participants. Completed in 29 June 2018.

Timeline

25 January 2017

Primary endpoint
1 June 2018

29 June 2018

Quick facts

Lead sponsor	Yale University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	28,291
Start date	25 January 2017
Primary completion	1 June 2018
Estimated completion	29 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Sentinel lymph node biopsy (SLNB)

Conditions studied

• Ductal Carcinoma In Situ — all drugs for Ductal Carcinoma In Situ →

Sponsor

Yale University

Who can join

Adults 67 to 94, female only, with Ductal Carcinoma In Situ. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Primary · From the first BCS to 9 months post-diagnosis.

Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.

Number of participants with any side effects

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	534
Matched Aim 1 Cohort: SLNB	404

Number of participants with lymphedema

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	23
Matched Aim 1 Cohort: SLNB	60

Number of participants with wound Infection

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	453
Matched Aim 1 Cohort: SLNB	296

Number of participants with seroma

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	179
Matched Aim 1 Cohort: SLNB	153

Number of participants with pain

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	365
Matched Aim 1 Cohort: SLNB	237

Receipt of Mastectomy Secondary · 6 months within DCIS diagnosis

Secondary outcomes for Aim 1: receipt of mastectomy with and without SLNB after initial BCS through 6 months after DCIS diagnosis.

Yes

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	237
Matched Aim 1 Cohort: SLNB	413

No

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	4481
Matched Aim 1 Cohort: SLNB	1996

Receipt of Radiation Therapy Secondary · 9 months within DCIS diagnosis

Secondary outcomes for Aim 1: Receipt of radiation therapy within 9 months of DCIS diagnosis.

Yes

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	2814
Matched Aim 1 Cohort: SLNB	1416

No

Group	Value	95% CI
Matched Aim 1 Cohort: No SLNB	1904
Matched Aim 1 Cohort: SLNB	993

Overall Survival Secondary · From 9 months post-diagnosis to death/end of study period (up to 1.5 years)

Secondary outcomes for Aim 2.

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	727
Matched Aim 2 Cohort: SLNB	287

Lasting Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Secondary · From 9 months post-diagnosis to death/end of study period (up to 1.5 years)

Secondary outcomes for Aim 2: unadjusted side effects (any side effects, lymphedema, any infection, seroma, pain) in the matched sample by use of sentinel lymph node biopsy (SLNB). Any side effects refer to the occurrence of one or more of the following complications since diagnosis of DCIS: lymphedema related complications, any infection, seroma, and any pain.

Number of participants with any side effects

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	2329
Matched Aim 2 Cohort: SLNB	1204

Number of participants with lymphedema

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	159
Matched Aim 2 Cohort: SLNB	123

Number of participants with any infection

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	1579
Matched Aim 2 Cohort: SLNB	751

Number of participants with seroma

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	294
Matched Aim 2 Cohort: SLNB	186

Number of participants with pain

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	1283
Matched Aim 2 Cohort: SLNB	701

Breast Cancer Specific Mortality Secondary · From 9 months post-diagnosis to death/end of study period (up to 1.5 years)

Primary outcomes for Aim 2: Breast cancer specific mortality from 9 months post-diagnosis to death or the end of the study period (December, 2014).

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	36
Matched Aim 2 Cohort: SLNB	19

Ipsilateral Invasive Breast Cancer Occurrence Secondary · From 9 months post-diagnosis to death/end of study period (up to 1.5 years)

Primary outcomes for Aim 2: Ipsilateral invasive breast cancer occurrence after 9 months of a DCIS diagnosis, per SEER reports.

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	150
Matched Aim 2 Cohort: SLNB	70

Treated Recurrence Secondary · From 9 months post-diagnosis to death/end of study period (up to 1.5 years)

Primary outcomes for Aim 2: Treated recurrence was defined by the receipt of mastectomy after 9 months of a DCIS diagnosis in the Aim 2 matched cohort.

Group	Value	95% CI
Matched Aim 2 Cohort: No SLNB	145
Matched Aim 2 Cohort: SLNB	78

Sponsor's own description

Patients with ductal carcinoma in situ (DCIS) treated with available therapies have experienced excellent outcomes and very low mortality rates due to the disease's non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a result, determining strategies to manage DCIS has been identified as a research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and needs further scrutiny. Our study addresses this evidence gap as the investigators propose a retrospective cohort study to investigate the outcome of SLNB among DCIS patients. Specifically, the investigators will compare the outcomes, including survival outcomes and treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims in this study: Aim 1: the investigators select our study sample using SEER-Medicare database. The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from \>9 months post-diagnosis to death or the end of this study period.

Given the nature of our observational study design, the investigators will apply standard multivariate analyses and propensity score methodology to reduce the influence from confounders. The investigators will control for patient demographics, comorbidities, functional status, tumor characteristics, and prior healthcare utilization. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.