Synonym | y trial | FU | N total | Med. Age | Stat Setting | Prim. EP | Pop | Strat | PBI Technique | PBI Dose | WBI Dose | G3 | DCIS | N+ | HR+ | Her2 neu | CTx | ET | Boost |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NSABP B-39 | 2005– 2013 | 10.2 | 4216 | 54 | Equiv | IBTR | IBC or DCIS; T < 3 cm, ≤ N1; R0; > 18y | Stage, Menopausal, ER, CTx | 3DCRT, single- and multicath. BT | 34/3.4; 38.5/3.85 10 × in 5-8d | 50/2; 50.4/1.8; opt. Boost | 26% | 24% | 10% | 81% | n.r | 29% | n.r | 80% |
Budapest | 1998– 2004 | 17 | 258 | Mean 59 | Noninf | LR | IBC; T < 2 cm; N0; R0; G1-2; unifocal | None | multicath. BT 3DCRT e- | BT:36.4/5.2 BID; e-:50/2 QD | 50/2 + opt. 16/2 | 0.0% | 0% | 3% N1mic | 88% | n.r | 3% | 99% | 0.8% |
RAPID | 02/2006– 07/2011 | 8.6 | 2135 | 61 | Noninf | IBTR | IBC or DCIS; T < 3 cm;R0; N0; > 40y; unifocal | Age > < 50; Histology, T > < 1.5 cm; ER, centre | 3DCRT IMRT | 38.5/3.85 BID in 5-8d | 50/2; 42.5/2.66 + opt. Boost | 16% | 18% | 0% | 84% | 6% | 13% | 55% | 21% |
IRMA | 2007– 2019 | 5 | 3309 | 65 | Noninf | IBTR | IDC; T < 2.5 cm; R0; > 45y; unifocal | Centre, timing | 3DCRT | 38.5/3.85 BID | 50/2; 50.4/1.8; 45/2.5 + opt. Boost 10–16/2 | n.r | 0% | 7% | 95% | n.r | 6% | 74% | n.r |
Barcelona | n.r | 10.3 | 102 | Mean 69 | Noninf | IBTR | IBC; T < 3 cm;R0; N0; > 60y; unifocal; G 1–2 | n.r | 3DCRT | 37.5/3.75 BID | 48/2 + opt. Boost 10/2 | 0.0% | 0% | 0% | 98% | 1% | 3% | 57% | n.r |
India | 06/2011–12/2015 | 5 | 133 | Mean 50 | Noninf | LR | IDC, T < 4 cm, cN0, pN0-1, R0 | None | 3DCRT | 34/3.4 BID | 40/2.5 + opt 10–16/2 | 23% | 0% | 12% | 69% | 11% | 65% | 74% | 56% |
Cairo | n.r | 2 | 91 | 50 | n.r | IBTR | IBC; T < 3 cm;R0; N0; > 40y;unifocal; G1-3 | n.r | 3DCRT | 38,5/3,85 QD 38.5/3.85 BID | 50/2 + opt. Boost | n.r | 0% | 0% | 80% | n.r | 19% | n.r | n.r |
Florence | 03/2005– 06/2013 | 10.7 | 520 | n.r | noninf | IBTR | IBC or DCIS; T < 2.5 cm; > 40y; BCS + | None | IMRT | 30/6 q.o.d | 50/2 + opt. Boost 10/2 | 11.4% | 11% | 10% | 96% | 4% | 7% | 62% | n.r |
Import low | 05/2007– 10/2010 | 6 | 1343 | 62 | noninf | IBTR | IDC; T < 3 cm; > 50y; pN0-1 | Centre | 3DCRT | 40/2.67 QD | 40/2.67 | 9.7% | 0% | 3% | 95% | 4% | 5% | 80% | n.r |
DBCG PBI | 2009– 2016 | 7.6 | 882 | 66 | noninf | Breast Induration 3y | IBC, T1, R0, > 60y, G1-2, HER2-, pN0 | Centre, ET | 3DCRT | 40/2.67 QD | 40/2,67 | < 1.0% | 0% | 0% | 100% | 0% | n.r | 80% | n.r |
HYPAB | 01/2015–01/2018 | 3 | 172 | 64 | n.r | Cosmetic outcome | Postmen. T1-2 pN0, unicentric, R0 (5 mm), No EIC | n.r | VMAT | 30/6 alternate days | 40.5/2.7 48/3.2 | 3% | n.r | 0% | 100% | n.r | n.r | 97% | 100% |
Beijing | 06/2017– 01/2019 | 1 | 115 | 54 | noninf | Grade II + Tox | 45-75y, G1-2, T < 3 cm, pN0, unifocal, ER/PR + , R0 (2 mm) | None | IMRT | 40/4 QD | 43.5/2.9 Opt. SIB 49.5/3.3 | 0% | n.r | 0% | 100% | 7% | 21% | n.r | 3% |
ELIOT | 11/2000– 12/2007 | 12.4 | 1305 | n.r | noninf | IBTR | IBC; T < 2.5 cm; R0; 48-75y; unifocal | T < 1–1.4 > cm | IORT e- | 21/21 | 50/2 + opt. Boost 10/2 | 20.9% | 0% | 27% | 91% | 3% | 8% | 88% | n.r |
TARGIT-A prepathology | 03/2000– 06/2012 | 8.6 | 2298 | Mean 63 | noninf | LRFS | IDC; T < 2.5 cm; R0; > 45y; unifocal | Centre, timing | IORT x | 20/20 | n.r | 20% | 0% | ~ 21% | 90% | 15% | 21% | 81% | 38% |
TARGIT-A postpathology | 03/2000– 06/2012 | 9 | 1153 | Mean 63 | noninf | LRFS | IDC; T < 2.5 cm; R0; > 45y; unifocal | Centre, timing | IORT x | 20/20 | n.r | 6% | 3% | 5% | 98% | 6% | 4% | 87% | n.r |
GEC Estro | 04/2004– 07/2009 | 10.4 | 1328 | 62 | noninf | IBTR | IBC or DCIS; T < 3 cm; R0; N0; > 40y; BCS + | Centre, Menopausal, stage | multicath. BT | 32/4; 30.3/4.3 or PDR | 50/2; 50.4/1.8; Boost opt | 8.3% | 5% | 6% | 95% | n.r | 11% | 90% | 98% |