A phase ib study of alpelisib or buparlisib combined with tamoxifen plus goserelin in premenopausal women with HR-positive HER2-negative advanced breast cancer
Journal
Clinical Cancer Research
Journal Volume
27
Journal Issue
2
Pages
408-417
Date Issued
2021
Author(s)
Lee K.S.
Chao T.-Y.
Tseng L.-M.
Chitapanarux I.
Chen S.-C.
Liu C.-T.
Sohn J.
Kim J.H.
Chang Y.-C.
Yang Y.
Shotelersuk K.
Jung K.H.
Valenti R.
Slader C.
Gao M.
Park Y.H.
Abstract
PURPOSE: ) advanced breast cancer (ABC). PATIENTS AND METHODS: = 13) in 28-day cycles until MTD was observed. RESULTS: The criteria for MTD were not met for both alpelisib and buparlisib. The RP2D of alpelisib and buparlisib in combination with tamoxifen and goserelin were 350 mg and 100 mg, respectively. Both combinations met protocol-specified criteria for tolerability. The most common grade 3/4 treatment-emergent adverse events (TEAE) were hypokalemia (12.5%), hyperglycemia (6.3%), and rash (6.3%) for alpelisib and alanine aminotransferase increase (30.8%), aspartate aminotransferase increase (23.1%), and anxiety (15.4%) for buparlisib. TEAEs led to treatment discontinuation in 18.8% and 53.8% of alpelisib- and buparlisib-treated patients, respectively. Progression-free survival was 25.2 months in the alpelisib group and 20.6 months in the buparlisib group. CONCLUSIONS: .
SDGs
Publisher
American Association for Cancer Research Inc.
Type
journal article