A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer

Summary

Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy in hormone receptor-positive MBC, the purpose of this phase Ib trial is to assess the maximum tolerated dose (MTD) and/or the RP2D(s), to characterize the safety and tolerability, to determine the single and multiple dose PK profile and assess the preliminary anti-tumor activity of alpelisib and buparlisib in combination with tamoxifen plus goserelin acetate in premenopausal hormone receptor-positive advanced breast cancer patientsgroup.

Timeline

Start

2014-05-06

Primary completion

2018-06-19

Completion

2018-06-19

Publications

• Lu YS, Lee KS, Chao TY, Tseng LM, Chitapanarux I, Chen SC, Liu CT, Sohn J, Kim JH, Chang YC, Yang Y, Shotelersuk K, Jung KH, Valenti R, Slader C, Gao M, Park YH. A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer. Clin Cancer Res. 2021 Jan 15;27(2):408-417. doi: 10.1158/1078-0432.CCR-20-1008. Epub 2020 Jul 27.

Drugs

Indications