drugset
drugset / Trial / NCT02167854

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

NCT02167854 ↗

Phase 1 Completed 23 enrolled Memorial Sloan Kettering Cancer Center Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I study. The purpose of this study is to determine what is the best dose of the study drug BYL719 in combination with the study drug LJM716 and traztuzumab (Herceptin®). The study will test the safety of the combination of these three drugs, and to find out the effects, good and/or bad, that these three drugs have on the patient and breast cancer.

Timeline

Start
2014-06-16
Primary completion
2021-07-07
Completion
2021-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 250 mg Oral
Subject ELGEMTUMAB Monoclonal antibody 10 mg/kg —
Subject ELGEMTUMAB Monoclonal antibody 20 mg/kg —
Subject Trastuzumab Monoclonal antibody 2 mg/kg —

Indications

breast cancer