Table 2.

Summary of Current DCIS Active Surveillance Trials

	COMET	LORIS	LORD
Primary Outcome	Ipsilateral IDC incidence	Ipsilateral IDC survival	Ipsilateral IDC incidence
Target enrollment	1,200	932	1,240
Randomization	1:1	1:1	1:1
Year initiated	2017	2014	2017
Recruitment duration	4 years	6 years	4 years
Follow-up interval	5–7 years	10 years	10 years
Imaging surveillance	Biannual mammogram	Annual mammogram	Annual mammogram
Treatment	May get endocrine therapy	May get endocrine therapy	None
Inclusion criteria
Age (years)	≥40	≥46	≥45
Nuclear grade	Low and intermediate	Low risk*	Low
Appearance	Calcifications only	Calcifications only	Calcifications only
Receptor status	ER/PR+ and HER2-	N/A	N/A
Biopsy technique	VACB or surgical biopsy	VACB and/or surgical biopsy	VACB: 6 cores with 8/9 gauge or 12 cores with 10/11 gauge
Exclusion criteria
History of cancer	Exclude if IDC or DCIS	Exclude if IDC or ipsilateral DCIS	Exclude all prior cancers except cervical in situ or basal carcinoma
Symptomatic	Exclude	Exclude	Exclude
Comedonecrosis	Exclude	Exclude	N/A
Synchronous IDC	Exclude	Exclude	Exclude
Bilateral DCIS	Include	Include	Exclude
High risk	Include	Exclude if high risk per NICE guidelines	Exclude if family with BRCA 1/2 mutation

Abbreviations: IDC, invasive ductal carcinoma; DCIS, ductal carcinoma in situ; VACB, vacuum-assisted core biopsy; NICE, National Institute for Health Care and Excellent (United Kingdom)

* The LORIS trial uses a central pathology review and stratifies DCIS into low and high risk. Low-risk DCIS includes low nuclear grade and the bottom half of intermediate nuclear grade.