Table 1.
GEC-ESTRO | ELIOT | TARGIT-A | IMPORT LOW | OCOG-RAPID | NSABP-B39/RTOG 0413 | University of Florence | |
---|---|---|---|---|---|---|---|
Number of patients randomized | n = 1184 | n = 1305 | n = 3451 | n = 2018 | n = 2135 | n = 4216 | n = 520 |
Primary endpoint/trial design | Local recurrence/non-inferiority trial | IBTR/non-inferiority trial | IBTR/non-inferiority trial | IBTR/non-inferiority trial | IBTR/non-inferiority trial | IBTR/equivalence trial | IBTR/equivalence trial |
Median follow-up | 6.6 years | 5.8 years | 2.4 years | 6 years | 8.6 years | 10.2 years | 10 years |
Study eligibility/exclusion criteria |
≥ 40 years Negative surgical margins (≥ 2 mm for IDC, ≥ 5 mm for ILC) ≤ 3 cm, pN0/pN1mi Unifocal Pure DCIS allowed if Van Nuys Prognostic index score < 8 Grade I-III LVI & EIC excluded Paget’s or skin involvement excluded |
48–75 years All histologies and grades eligible Suitable for BCS ≤ 2.5 cm |
≥ 45 years IDC Suitable for BCS Unifocal on conventional imaging |
≥ 50 years IDC (ILC excluded) Negative surgical margins (≥ 2 mm) ≤ 3 cm, pN0–1 grade I-III LVI allowed Unifocal |
≥ 40 years IDC (ILC excluded) Negative surgical margins ≤ 3 cm (invasive and in situ combined), pN0-N1mi or N0i+ Pure DCIS allowed Grade I-III LVI allowed Multicentric excluded |
> 18 years All histologies and grades eligible Negative surgical margins ≤ 3 cm, pN0–1 DCIS allowed Unifocal/multifocal only (multicentric excluded) |
> 40 years IDC/lobular carcinoma Negative surgical margins (≥ 5 mm) ≤ 2.5 cm, pN0-N1 Pure DCIS Grade I-III LVI allowed Unifocal only EIC excluded |
IBTR ipsilateral breast tumor recurrence, EIC extensive intraductal component, LVI lymphovascular invasion, DCIS ductal carcinoma in situ, LCIS lobular carcinoma in situ, mi micrometastases, i+ isolated tumor cells, IDC invasive ductal carcinoma, ILC invasive lobular carcinoma, BCS breast conserving surgery