A Phase III Study of Sacituzumab Govitecan in Patients with Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer

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Full Title

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician’s Choice (TPC) in Subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

Purpose

The purpose of this study is to assess the effectiveness of the investigational drug sacituzumab govitecan in patients with hormone receptor-positive HER2-negative metastatic breast cancer that persists despite prior chemotherapy. Sacituzumab govitecan is a chemotherapy drug attached to an antibody. The antibody part binds to a type of cancer-causing cell, and the chemotherapy drug stops the cell’s ability to grow.

Patients in this study will be randomly assigned to receive sacituzumab govitecan or a standard chemotherapy regimen (eribulin, capecitabine, gemcitabine, or vinorelbine). All treatments are given intravenously (by vein) except for capecitabine, which 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 hormone receptor-positive HER2-negative metastatic breast cancer that came back or continues to grow despite at least 2 but no more than 4 prior regimens of therapy that included a taxane drug, hormonal therapy, and a CDK inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 and to inquire about eligibility for this study, please contact Danielle Gerome at 646-888-5157 to speak with a nurse.

Protocol

19-365

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators