A Phase IB Study of Debio 1347 plus Fulvestrant in Women with Metastatic Breast Cancer

Full Title

IIT: A Phase Ib/II Study of Debio 1347 Plus Fulvestrant in Patients with FGFR-Amplified Endocrine Receptor Positive Metastatic Breast Cancer

Purpose

The purpose of this study is to find the highest dose of an investigational drug called Debio 1347 that can be given safely with another drug called fulvestrant in women with metastatic breast cancer. Debio 1347 works by blocking molecules in the FGFR family of proteins: molecular signals in cancer cells that, when turned on, can make cancers grow faster and bigger. Doctors believe that combining Debio 1347 with a hormonal therapy such as fulvestrant could lead to greater tumor shrinkage in patients with breast cancers that have estrogen receptors and FGFR.

Debio 1347 is taken orally (by mouth) and fulvestrant is given as an injection.

Eligibility

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

  • Patients must be women with metastatic breast cancer that is positive for estrogen and/or progesterone receptors and negative for HER2, and produces high amounts of FGFR.
  • 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 Micaela Rodine or Yasmine Hemida at 646-888-5157.

Protocol

17-379

Phase

I/II

Investigator

Co-Investigators

Diseases