Table 2.

Baseline disease characteristics, SOLAR-1 (7).

PIK3CA-mutant tumorsPIK3CA nonmutant tumors
Alpelisib + fulvestrantPlacebo + fulvestrantAll patientsAlpelisib + fulvestrantPlacebo + fulvestrantAll patients
n = 169 (%)n = 172 (%)n = 341 (%)n = 115 (%)n = 116 (%)n = 231 (%)
Sites of metastases
 Breast1 (1)3 (2)4 (1)5 (4)4 (3)9 (4)
 Bone
  Any131 (78)121 (70)252 (74)79 (69)89 (77)168 (73)
  Only42 (25)35 (20)77 (23)26 (23)23 (20)49 (21)
 Visceral
  Any93 (55)100 (58)193 (57)66 (57)74 (64)140 (61)
  Liver49 (29)54 (31)103 (30)41 (36)36 (31)77 (33)
  Lung57 (34)68 (40)125 (37)37 (32)55 (47)92 (40)
Number of metastatic sites
 001 (1)1 (<1)000
 163 (37)52 (30)115 (34)44 (38)33 (29)77 (33)
 258 (34)60 (35)118 (35)35 (30)38 (33)73 (32)
 ≥348 (28)59 (34)107 (31)36 (31)45 (39)81 (35)
Prior treatment
 Any CDK 4/6 inhibitor9 (5)11 (6)20 (6)7 (6)8 (7)15 (7)
 Tamoxifen59 (35)62 (36)121 (36)37 (32)50 (43)87 (37)
 Chemotherapy101 (60)107 (62)208 (61)78 (68)72 (62)150 (65)
 Neoadjuvant25 (15)29 (17)54 (16)20 (17)23 (20)43 (19)
 Adjuvant78 (42)86 (50)164 (48)64 (56)58 (50)122 (53)
Line of treatment in advanced disease
 First line88 (52)89 (52)177 (52)72 (63)61 (53)133 (58)
 Second line79 (47)82 (48)161 (47)44 (38)52 (45)96 (42)
Endocrine status
 Primary resistance23 (14)22 (13)45 (13)31 (27)26 (22)57 (25)
 Secondary resistance120 (71)127 (74)247 (72)66 (57)65 (56)131 (57)
 Sensitive20 (12)19 (11)39 (11)16 (14)20 (17)36 (16)
  • Note: Percentages in the table for each category may not sum to 100% due to rounding.