Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Hope Rugo

Description

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.

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

Keywords

Advanced or Metastatic ER+ Breast Cancer LSZ102 LEE011 ribociclib Kisqali BYL719 alpelisib ER+ breast cancer advanced ER+ breast cancer metastatic ER+ breast cancer SERD SERM fulvestrant tamoxifen aromatase inhibitor ESR1 mtESR1 wtESR1 estrogen receptor endocrine therapy Breast Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94115 United States
  • Novartis Investigative Site accepting new patients
    Houston Texas 77030 United States

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02734615
Phase
Phase 1
Study Type
Interventional
Last Updated