A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer.
Yen-Shen LuKeun Seok LeeTsu-Yi ChaoLing-Ming TsengImjai ChitapanaruxShin-Cheh ChenChien-Ting LiuJoohyuk SohnJee Hyun KimYuan-Ching ChangYoungsen YangKanjana ShotelersukKyung Hae JungRoberta ValentiCassandra SladerMelissa GaoYeon Hee ParkPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2020)
The RP2Ds of alpelisib and buparlisib were 350 mg and 100 mg, respectively. No unexpected safety findings were reported. Although an early-phase study, data suggest that alpelisib plus endocrine therapy may be a potentially efficacious treatment that warrants further evaluation for premenopausal patients with HR+, HER2- ABC.See related commentary by Clark et al., p. 371.
Keyphrases
- postmenopausal women
- breast cancer risk
- open label
- electronic health record
- randomized controlled trial
- big data
- early breast cancer
- clinical trial
- stem cells
- machine learning
- breast cancer cells
- young adults
- mesenchymal stem cells
- positive breast cancer
- combination therapy
- study protocol
- data analysis
- drug induced
- smoking cessation
- placebo controlled