Table 1
| SWOG/ Support |
STUDY | R E G |
O P E N |
ARM | ACCR. GOAL |
TOTAL REGS. |
REGS. LAST 12 Month |
REGS. LAST 6 Month |
REGS. LAST 3 Month |
REGS. LAST 30 DAYS |
REGS. LAST 7 DAYS |
DATE OF FIRST REG. |
# of ACT. INSTs |
# of CURR IRBs |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SWOG | S1007-Breast,Adj,N1,Endocrine+/-Chemo | 1 | Y | 1 Recurrence Score testing | 9400 | 9383 | 327 | 0 | 0 | 0 | 0 | 02/28/2011 | 439 | 211 |
| 9383 | 327 | 0 | 0 | 0 | 0 | |||||||||
| 2 | Y | 2 Chemo and Endocrine Therapy | 5000 | 2547 | 122 | 0 | 0 | 0 | 0 | 02/28/2011 | ||||
| 3 Endocrine Therapy Alone | 2536 | 121 | 0 | 0 | 0 | 0 | ||||||||
| 5083 | 243 | 0 | 0 | 0 | 0 | |||||||||
| S1207-Brst,Adj,Endocrine+/-Everolimus | 1 | Y | 1 Blinded drug + Endocrine | 1900 | 785 | 185 | 93 | 49 | 18 | 2 | 09/12/2013 | 463 | 242 | |
| 2 Blinded drug + Endocrine | 791 | 198 | 90 | 44 | 16 | 1 | ||||||||
| 1576 | 383 | 183 | 93 | 34 | 3 | |||||||||
| S1222-Brst,Fulv. +/- Ever. +/- Anastr. | 1 | T | 1 Blinded treatment | 840 | 12 | 0 | 0 | 0 | 0 | 0 | 05/15/2014 | 22 | 6 | |
| 2 Blinded treatment | 12 | 0 | 0 | 0 | 0 | 0 | ||||||||
| 3 Blinded treatment | 13 | 0 | 0 | 0 | 0 | 0 | ||||||||
| 37 | 0 | 0 | 0 | 0 | 0 | |||||||||
| S1416-Brst, TNBC/BRCA, Cis+/- ABT-888 | 1 | Y | 1 Blinded Drug + Cisplatin | 333 | 123 | 88 | 41 | 18 | 6 | 0 | 09/15/2016 | 279 | 132 | |
| 2 Blinded Drug + Cisplatin | 121 | 88 | 41 | 17 | 6 | 0 | ||||||||
| 244 | 176 | 82 | 35 | 12 | 0 | |||||||||
| S1418-Breast, Adj, TNBC, MK-3475 (Pembrolizumab) | 1 | Y | 1 Tissue for PD-L1 testing | 1000 | 205 | 187 | 112 | 62 | 15 | 4 | 01/18/2017 | 412 | 188 | |
| 205 | 187 | 112 | 62 | 15 | 4 | |||||||||
| 2 | Y | 2 Observation | 1000 | 92 | 88 | 53 | 30 | 14 | 0 | 01/18/2017 | ||||
| 3 MK-3475 (Pembrolizumab) | 86 | 80 | 46 | 28 | 6 | 0 | ||||||||
| 178 | 168 | 99 | 58 | 20 | 0 | |||||||||
| Yes | A011106-Breast, Neoadj, ALTERNATE study | 1 | E | Total Registrations | 56 | 22 | 6 | 3 | 3 | 0 | 04/29/2014 | 263 | 123 | |
| 56 | 22 | 6 | 3 | 3 | 0 | |||||||||
| E1Z11-Brst,Genetic Predictors of AIMSS | 1 | E | Total Registrations | 150 | 10 | 6 | 2 | 0 | 0 | 08/13/2013 | 218 | 80 | ||
| 150 | 10 | 6 | 2 | 0 | 0 | |||||||||
| No | A011202-Breast, Nodal XRT +/- ALND | 0 | E | Total Registrations | 169 | 58 | 27 | 14 | 6 | 1 | 03/20/2014 | 357 | 189 | |
| 169 | 58 | 27 | 14 | 6 | 1 | |||||||||
| 1 | E | Total Registrations | 67 | 21 | 10 | 6 | 3 | 0 | 03/20/2014 | |||||
| 67 | 21 | 10 | 6 | 3 | 0 | |||||||||
| A011401-Breast, adj, Stage II/III HER2-, weight loss | 1 | E | Total Registrations | 133 | 104 | 55 | 31 | 9 | 3 | 10/05/2016 | 435 | 234 | ||
| 133 | 104 | 55 | 31 | 9 | 3 | |||||||||
| 2 | E | Total Registrations | 117 | 94 | 49 | 29 | 7 | 0 | 10/05/2016 | |||||
| 117 | 94 | 49 | 29 | 7 | 0 | |||||||||
| A011502-Brst, Adj, Nodal+&HER2-, Aspirin vs. Placebo | 1 | E | Total Registrations | 35 | 33 | 16 | 11 | 6 | 4 | 03/20/2017 | 219 | |||
| 35 | 33 | 16 | 11 | 6 | 4 | |||||||||
| A221405-Breast, ET interruption, Pregnancy Outcomes | 1 | E | Total Registrations | 9 | 9 | 5 | 1 | 0 | 0 | 05/08/2017 | 63 | |||
| 9 | 9 | 5 | 1 | 0 | 0 | |||||||||
| B51-Breast, Regional Nodal XRT | 1 | E | Total Registrations | 25 | 13 | 4 | 0 | 0 | 0 | 06/13/2014 | 421 | 223 | ||
| 25 | 13 | 4 | 0 | 0 | 0 | |||||||||
| B55-Brst, Adj Olaparib for BRCA,TNBC | 1 | E | Total Registrations | 57 | 19 | 12 | 5 | 2 | 0 | 12/15/2014 | 425 | 186 | ||
| 57 | 19 | 12 | 5 | 2 | 0 | |||||||||
| 2 | E | Total Registrations | 24 | 9 | 4 | 1 | 1 | 0 | 12/15/2014 | |||||
| 24 | 9 | 4 | 1 | 1 | 0 | |||||||||
| E2112-Brst,Adv,Exemestane+/-Entinostat | 1 | E | Total Registrations | 46 | 15 | 6 | 2 | 0 | 0 | 04/01/2015 | 296 | 165 | ||
| 46 | 15 | 6 | 2 | 0 | 0 | |||||||||
| EA1131-Brst, TNBC, Post-op Chemo vs Obs | 0 | E | Total Registrations | 18 | 10 | 4 | 3 | 2 | 0 | 11/12/2015 | 318 | 136 | ||
| 18 | 10 | 4 | 3 | 2 | 0 | |||||||||
| 1 | P | Total Registrations | 9 | 8 | 2 | 1 | 1 | 0 | 11/12/2015 | |||||
| 9 | 8 | 2 | 1 | 1 | 0 | |||||||||
| EA1151-Brst, Tomosynthesis Mammographic Screening | 1 | E | Total Registrations | 60 | 60 | 60 | 60 | 30 | 5 | 01/30/2018 | 51 | |||
| 60 | 60 | 60 | 60 | 30 | 5 | |||||||||
| NRGBR002-Brst, OMBC, II-III, SoC +/- SBRT and/or SA | 1 | E | Total Registrations | 1 | 1 | 0 | 0 | 0 | 0 | 09/22/2017 | 28 | |||
| 1 | 1 | 0 | 0 | 0 | 0 | |||||||||
| NRGBR003-Brst,Adj,TNBC,AC -> WP +/- Carbo | 1 | E | Total Registrations | 51 | 23 | 7 | 3 | 0 | 0 | 10/16/2015 | 435 | 211 | ||
| 51 | 23 | 7 | 3 | 0 | 0 | |||||||||