SAS Output

10-APR-2021 6:10

BREAST ACCRUAL REPORT - Open and Recently Closed Studies

The REPORT Procedure

Detailed and/or summarized report

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 S1418-Breast, Adj, TNBC, MK-3475 (Pembrolizumab) 1 Y 1 Tissue for PD-L1 testing 1000 1239 367 177 84 34 5 01/18/2017 415 209
            1239 367 177 84 34 5      
 
    2 Y 2 Observation 1000 530 151 78 38 14 4 01/18/2017    
        3 MK-3475 (Pembrolizumab)   540 169 83 39 15 5      
            1070 320 161 77 29 9      
 
  S1706-Breast, Inflammatory, RT +/- Olaparib 1 Y 1 Olaparib + RT 300 38 22 7 1 0 0 01/18/2019 201 100
        2 RT   40 18 10 8 4 2      
            78 40 17 9 4 2      
 
Yes A011202-Breast, Nodal XRT +/- ALND 0 E Total Registrations   252 23 11 7 1 0 03/20/2014 310 170
            252 23 11 7 1 0      
 
    1 E Total Registrations   112 10 3 3 1 0 03/20/2014    
            112 10 3 3 1 0      
 
  A011801-BRST, HER2+, T-DM1+Placebo v T-DM1+Tucatinib 1 E Total Registrations   1 1 1 1 1 0 03/11/2021 14 11
            1 1 1 1 1 0      
 
  EA1131-Brst, TNBC, Post-op Chemo vs Obs 0 E Total Registrations   44 7 6 1 0 0 11/12/2015 276 129
            44 7 6 1 0 0      
 
    1 E Total Registrations   30 6 5 1 1 0 11/12/2015    
            30 6 5 1 1 0      
 
  EA1181-BRST, HER2-pCR, Preop THP and Postop HP 1 E Total Registrations   16 15 12 11 2 0 03/17/2020 192 110
            16 15 12 11 2 0      
 
  EA1183-Brst, Met, FDG PET Assess Response, FEATURE 1 E Total Registrations   2 2 2 1 0 0 01/06/2021 7 6
            2 2 2 1 0 0      
 
  MA39-BREAST, Node-Pos, Reg RT vs No Reg RT 1 E Total Registrations   4 3 2 2 1 0 10/18/2019 253 112
            4 3 2 2 1 0      
 
    2 E Total Registrations   3 2 1 1 0 0 10/18/2019    
            3 2 1 1 0 0      
 
  NRGBR002-Brst, OMBC, II-III, SoC +/- SBRT and/or SA 1 T Total Registrations   1 0 0 0 0 0 09/22/2017 199 98
            1 0 0 0 0 0      
 
  NRGBR003-Brst,Adj,TNBC,AC -> WP +/- Carbo 1 E Total Registrations   87 3 2 1 0 0 10/16/2015 310 153
            87 3 2 1 0 0      
 
  NRGBR004-BREAST, Met HER2+, Pac+Tras+Pert +/- Atezo 1 E Total Registrations   7 4 2 1 0 0 11/04/2019 362 160
            7 4 2 1 0 0      
 
    2 E Total Registrations   4 2 1 1 0 0 11/04/2019    
            4 2 1 1 0 0      
 
  NRGBR005-Br, Stg II&IIIA, Post NAdj Chemo Br Conserv 1 T Total Registrations   7 0 0 0 0 0 06/22/2018 187 75
            7 0 0 0 0 0      
 
No A011401-Breast, adj, Stage II/III HER2-, weight loss 1 E Total Registrations   333 33 18 11 0 0 10/05/2016   225
            333 33 18 11 0 0      
 
    2 E Total Registrations   312 33 19 11 0 0 10/05/2016    
            312 33 19 11 0 0      
 
    3 E Total Registrations   83 83 83 73 15 2 10/05/2016    
            83 83 83 73 15 2      
 

10-APR-2021 6:10

BREAST Open Studies with No Registrations

The REPORT Procedure

Detailed and/or summarized report

Table 1

Study Registration/Phase Open Date # of
ACT.
INSTs
# of
CURR
IRBs
S2007 Breast, Brain Mets, Sacituzumab Govitecan 1 Registration 15-Dec-20 48 25