Breast Cancer Clinical Trial

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

199

Study ID:

NCT02734615

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 10 Locations for this study

See Locations Near You

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?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

199

Study ID:

NCT02734615

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

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