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Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers 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.
View Eligibility Criteria Eligibility Criteria 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.
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There are 10 Locations for this study
Massachusetts General Hospital Massachusetts General Hospital Boston Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center New York New York, 10065, United States
MD Anderson Cancer Center SC - LSZ102X2101 Houston Texas, 77030, United States
Novartis Investigative Site Bruxelles , 1200, Belgium
Novartis Investigative Site Lyon Cedex , 69373, France
Novartis Investigative Site Ulm , 89081, Germany
Novartis Investigative Site Milano MI, 20133, Italy
Novartis Investigative Site Milano MI, 20141, Italy
Novartis Investigative Site Koto ku Tokyo, 135 8, Japan
Novartis Investigative Site Singapore , 16961, Singapore
How clear is this clinincal trial information?
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