A Phase I/IB Study of LSZ102 Alone and with LEE011 or BYL719 in Patients with Metastatic Estrogen Receptor-Positive Breast Cancer

Full 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

Purpose

Researchers in this study want to find the best dose of the investigational drug LSZ102 to give alone and in combination with other investigational anticancer drugs in patients with metastatic estrogen receptor-positive breast cancer that has continued to grow despite hormonal therapy. The two other drugs are LEE011 and BYL719.

LSZ102 works by destroying the estrogen receptor. Breast cancers that are estrogen receptor-positive are fueled by estrogen, so destroying the receptors for this hormone may inhibit cancer growth. LEE011 blocks a protein called CDK, which tells cancer cells to divide. Researchers hope LEE011 will slow the growth of cancer cells and lead to their death. BYL719 is an inhibitor of PI3 kinase, an enzyme which fuels the growth of several types of cancer, including many breast cancers.

Patients in this study will receive LSZ102 alone, LSZ102 plus LEE011, or LSZ102 plus BYL719. All of the drugs used in this study are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic estrogen receptor-positive breast cancer that continues to grow despite hormonal therapy.
  • Patients must recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, contact Dr. Komal Jhaveri at 646-888-5157.

Protocol

16-740

Phase

I

Investigator

Diseases