Table 1.
Main features of the four prospective international study protocols (LORIS, COMET, LORD and LORETTA).
| Study | LORIS [11] | COMET [12] | LORD [13] | LORETTA [14] |
|---|---|---|---|---|
| Country | UK | USA | EU | JAPAN |
| Year of activation | 2014 | 2017 | 2017 | 2017 |
| Accrual target (number of patients) | 932 | 1200 | 1240 | 340 |
| Size of the lesion | Any | Any | Any | <2.5 cm |
| Type of guide for biopsy | Stereotactic (vacuum assisted) | Stereotactic (vacuum assisted) | Stereotactic (vacuum assisted) | Stereotactic and ultrasound (vacuum assisted) |
| Hormone receptor status | Any | Hr*-positive only | Any | Hr*-positive only |
| Endocrine therapy | Optional | Optional | Not allowed | Mandatory |
| Minimum age at diagnosis | 48 | 40 | 45 | 40 |
| Comedonecrosis | Excluded | Allowed | Excluded | Excluded |
Hr*: Hestrogen receptor.