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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

From: Accelerated Partial Breast Irradiation (APBI): A review of available techniques

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