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

Status:	Recruiting
Conditions:	Breast Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/20/2019
Start Date:	June 14, 2016
End Date:	October 30, 2020
Contact:	Novartis Pharmaceuticals
Email:	Novartis.email@novartis.com
Phone:	1-888-669-6682

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

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

Other protocol defined inclusion/exclusion criteria may apply.

We found this trial at

sites

Novartis

230 Park Avenue, 21st Floor
New York, New York 10169

1-888-669-6682)