A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
Advanced or Metastatic ER+ Breast Cancer
Active, not recruiting
Sep 09, 2020
Jun 14, 2016
Oct 30, 2020
18 Years and older (Adult, Older Adult)
Written informed consent must be obtained prior to any procedures
Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer
Advanced or metastatic breast cancer
Must be able to swallow tablets and capsules
Symptomatic CNS metastases
Patients whose laboratory values do not meet protocol criteria
Clinically significant cardiac disease
Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications
Other protocol defined inclusion/exclusion criteria may apply.
Massachusetts General Hospital Massachusetts General Hospital