Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

A treatment cycle will consist of 28 days. Treatment doses for trastuzumab and LJM716 will be fixed at trastuzumab 2mg/kg weekly, and LJM716 20mg/kg weekly. The exception to this is if dose de-escalation results in treatment of patients at dose level 1, where LJM will be dosed at 10mg/kg weekly. On Arm A, BYL719 was administered orally once daily continuously at one of 5 dosing levels, beginning with dose level 3, 250mg orally daily. On Arm B, BYL719 will be administered orally once daily during 4 of 7 days in a week, at one of 5 dosing levels, beginning with dose level 3, 250mg orally daily. This means BYL719 will be given to patients on Arm B during days 1-4, 8-11, 15-18, and 22-25 of each cycle. The dose-finding phase will follow a Continuous Reassessment Methods (CRM) phase I biostatistical design.

BYL719

LJM716

TRASTUZUMAB

Shanu Modi, MD

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.

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

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

The MTD is defined as per the Continual Reassessment Method. The RDE will be determined by the Principal Investigator with input from other investigators and Novartis, and will be based on the MTD, review of required intra-patient dose de-escalations, pharmacodynamic evaluations, and consideration of toxicities occurring in cycles 2+.

Novartis

Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for byl719 [alpelisib]