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Brief Title: Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
Official Title: 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
Study ID: NCT02734615
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
MD Anderson Cancer Center SC - LSZ102X2101, Houston, Texas, United States
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Koto ku, Tokyo, Japan
Novartis Investigative Site, Singapore, , Singapore
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR