SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer
Reshma L. Mahtani, D.O.
Summary
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Individuals ≥ 18 years of age. * 4\. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing on either the primary or any metastatic site. HER2 LOW is defined as: (IHC 2+/ISH- or IHC 1+ (ISH- or untested)) and HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%) * Histologically confirmed metastatic or advanced and unresectable b…
Interventions
- DrugSacituzumab govitecan
IV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated.
Locations (3)
- UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California
- Miami Cancer Institute at Baptist Health, Inc.Miami, Florida
- Winship Cancer Institute at Emory UniversityAtlanta, Georgia