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

Trial Status: Closed to Accrual

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


San Francisco
UCSF Medical Center-Mount Zion
Contact: UCSF Clinical Trials
Phone: 877-827-3222


Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE


Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Dejan Juric
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Dejan Juric
Phone: 617-761-5392

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Duke University Medical Center
Status: ACTIVE


M D Anderson Cancer Center

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CLSZ102X2101
  • Secondary IDs NCI-2016-00957, 2015-004016-38
  • ID NCT02734615