Table 7.
Prospective randomized phase II clinical APBI adapted from Offersen et al. [52] and Lehman and Hickey [152] WBI = whole breast irradiation, RAPID = randomized trial of accelerated partial breast irradiation
| Trial | Trial Design | N | Inclusion | Control Arm | APBI technique (Experimental Arm) | Status |
|---|---|---|---|---|---|---|
| TARGIT [123] | Equivalence | 2232 | ≥ 45 years T1 small T2, N0, 1, Ductal |
WBI as per institutional guidelines | IORT, Low energy X-rays 50 KV, 20 Gy/1 fraction | Started March 2000, completed enrollment march 2010 |
| ELIOT [115] | Equivalence | 824 | ≥ 48 years invasive carcinoma T ≤ 2.5 cm, pN0, Quadrantectomy |
WBI, 50 Gy/25 fractions + optional 10 Gy Boost | IORT 21 Gy/1 fraction, electrons up to 9 MeV | Started in Dec 2000 |
| GEC-ESTRO | Non-inferiority, non-irrelevant, 3% difference | 1170 | ≥ 40 years stages O-II ductal/lobular carcinoma T ≤ 3 cm, pNO-pNmi, margin ≥ 2 mm |
WBI 50- 50.4 Gy/25-28 fractions + optional 10 Gy boost | MIB, 32 Gy/8 fractions HDR, 30.3 Gy/7 fractions HDR, 50 Gy PDR | Started 2004 |
| NSABP/RTOG 0413 | Equivalence | 4300 | ≥ 18 years stage 0, I, II (T < 3 cm) DCIS or invasive adenocarcinoma, ≤ 3 nodes positive, Margin negative |
WBI 50-50.4 Gy/25-28 fractions, optional 10- 16 Gy boost |
MIB Mammosite 34 Gy/10 fractions (5-10 days) 3D EBCRT 38.5 Gy/10 fractions (5-10 days) |
Started in 2005 (accrual now closed to low risk patients) |
| RAPID | Equivalence | 2128 | ≥ 40 years DCIS or invasive carcinoma T< 3 cm, margin negative, node negative, not BRCA 1/BRCA 2 |
WBI 42.5 Gy/16 fractions/22 days (small breast) 50 Gy/25 fractions/35 days (large breast plus optional boost 10 Gy/4-5 fractions |
3D CRT 38.5 Gy/10 fractions (5-8 days) Minimum daily fraction separation 6 -8 hours |
Started in January 2006 |
| IMPORT-LOW | Non-inferiority | 1935 | ≥ 50 years invasive adenocarcinoma (not lobular) T ≤ 3 cm, margin ≥ 2 mm, node negative |
WBI 40 Gy/15 fractions/21 days |
EBRT (IMRT) Arm 1 40 Gy/15 fractions to primary tumour region + 36 Gy/15 fractions to low risk region Arm 2 40 Gy/15 fractions to primary tumour region |
Started in 2006 |
| IRMA | Non-inferiority | n/a | ≥ 49 years pT1-2 (< 3 cm) invasive carcinoma pN0- N1 Margins ≥ 2 mm |
WBI 45 Gy/18 fractions, or 50 Gy/25 fractions, or 50,4 Gy/28 fractions |
3D CRT 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours |
Started in 2007 |