Alpelisib plus endocrine therapy

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

In this cohort, median PFS was 11 months in the alpelisib-plus-fulvestrant arm compared with 5.7 months in the placebo-plus-fulvestrant arm (HRprogression or HRdeath, 0.65; 95% CI, 0.50−0.85; P < .001).

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

PFS did not differ between arms in the cohort of participants without PIK3CA variants (median PFS, 7.4 months in the alpelisib-plus-fulvestrant arm vs. 5.6 months in the placebo-plus-fulvestrant arm).

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

OS in the cohort with PIK3CA variants was a secondary end point. OS data are not yet mature.

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

Very few study participants had received previous CDK4/6 inhibitor therapy.

SOLAR-1 (NCT02437318) was a randomized phase III trial comparing alpelisib plus fulvestrant with placebo plus fulvestrant. The trial included 572 postmenopausal women with HER2-negative hormone receptor–positive advanced breast cancer who had received previous endocrine therapy.[33][Level of evidence B1] PIK3CA variants were confirmed in 341 participants. The primary end point was PFS in the cohort of patients with PIK3CA variants. The FDA approved alpelisib for use in combination with fulvestrant in advanced PIK3CA-mutated, HER2-negative hormone receptor–positive breast cancer after previous endocrine therapy.

Common toxicities associated with alpelisib included hyperglycemia, diarrhea, nausea, anorexia, and rash. Careful monitoring and management of hyperglycemia are required during alpelisib use.