A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Status:
Completed
Trial end date:
2018-06-19
Target enrollment:
Participant gender:
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.