Phase I / Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

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.

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Lead Organization
Novartis Pharmaceuticals Corporation