Table 1.

SOLAR-1 demographics, PIK3CA-mutated tumor and wild-type cohorts (7).

PIK3CA-mutated tumorsPIK3CA wild-type tumors
Alpelisib + fulvestrantPlacebo + fulvestrantAll patientsAlpelisib + fulvestrantPlacebo + fulvestrantAll patients
n = 169 (%)n = 172 (%)n = 341 (%)n = 115 (%)n = 116 (%)n = 231 (%)
Sex
 Female168 (99.4)172 (100)340 (99.7)115 (100)116 (100)231 (100)
 Male1 (0.6)01 (0.3)000
Age (years)
 Median636463626362
 Range25–8738–9225–9239–8232–8832–88
Age category (years)
 18 to <6595 (56)89 (52)184 (54)72 (63)65 (56)137 (59)
 65 to <8573 (43)80 (47)153 (45)43 (37)50 (43)93 (40)
 ≥851 (<1)3 (2)4 (1)01 (1)1 (<1)
Race
 White117 (69)109 (63)226 (66)82 (71)69 (60)151 (65)
 Asian34 (20)40 (23)74 (22)25 (22)26 (22)51 (22)
 Black or African American1 (1)3 (2)4 (1)1 (1)3 (3)4 (2)
 American Indian or Alaska Native1 (1)2 (1)3 (1)02 (2)2 (1)
 Other8 (5)10 (6)18 (5)1 (1)7 (6)8 (4)
 Unknown8 (5)8 (5)16 (5)6 (5)9 (8)15 (7)
ECOG
 0112 (66)113 (66)225 (66)84 (73)79 (68)163 (71)
 156 (33)58 (34)114 (33)30 (26)37 (32)67 (29)
 Missing1 (1)1 (1)2 (1)1 (1)01 (<1)
  • Note: Percentages in the table for each category may not sum to 100% due to rounding.

  • Abbreviation: ECOG, Eastern Cooperative Oncology Group.