HCC 19-045/132-09 – Sacituzumab Govitecan for Advanced Breast Cancer

STUDY BASICS

Do you have advanced HER2-negative, hormone receptor-positive breast cancer? Have you received 2-4 standard therapies for your breast cancer, but the cancer has progressed or reoccurred? You may be able to take part in a research study to find out if an experimental medication called sacituzumab govitecan is an effective treatment.

STUDY PURPOSE

Breast cancer that has spread to other parts of the body or reoccurred after treatment can be difficult to treat. The purpose of this study is to find out if an experimental (not FDA-approved) medication called sacituzumab govitecan is effective for people with advanced HER2-negative, hormone receptor-positive breast cancer who have received prior treatment. In this research study, researchers will compare sacituzumab govitecan with standard breast cancer treatments including eribulin, capecitabine, gemcitabine, and vinorelbine.

COULD THIS STUDY BE RIGHT FOR YOU?

• Diagnosed with breast cancer that has spread to other parts of the body (called metastatic breast cancer) or reoccurred after treatment
• Have already received 2-4 standard therapies for your breast cancer, but your breast cancer has progressed or returned

WHAT PARTICIPANTS CAN EXPECT

Participation involves an initial screening period of up to four weeks to find out if you are eligible for this study. Eligible participants will be randomly assigned (like drawing straws) to receive either the experimental treatment or one of the standard treatments for about 6 months. After study treatment is over, you will be contacted about every 2 months.

Tests and assessments during the study may include blood and urine collection, physical exam, biopsy, electrocardiogram, and CT or MRI scans.