A Phase I Study of AZD9496 in Women with Estrogen Receptor-Positive HER2-Negative Breast Cancer

Full Title

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women with Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer

Purpose

The purpose of this study is to find the highest dose of an investigational drug called AZD9496 that can be given safely in women with recurrent or metastatic estrogen receptor-positive HER2-negative breast cancer and to evaluate the preliminary effectiveness of this drug. AZD9496 works by breaking down estrogen receptors on breast cancer cells, making cancer-fueling estrogen unable to bind to the cancer cells and preventing breast cancer growth. AZD9496 is 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 recurrent or metastatic estrogen receptor-positive HER2-negative breast cancer that has continued to grow despite hormonal therapy.
  • Patients may have had up to two prior regimens of chemotherapy for advanced cancer.
  • At least 2 weeks must pass between the completion of prior therapy and entry into 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 women age 18 and older.

For more information about this study and to inquire about eligibility, contact Mtise Mwanza. The PI for this study is Komal Jhaveri, MD, FACP.

Protocol

15-330

Phase

I

Investigator

Diseases