SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer
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.
Arms & 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.
Outcome measures
Primary
Overall response rate (ORR)
ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator.
Time frame: 24 months
Secondary
Clinical benefit rate (CBR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 30 months
Overall survival (OS)
Time frame: 30 months
Duration of response (DOR)
Time frame: 30 months
Global Quality of Life
Time frame: 24 months
Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 30 months
Laboratory and Vital Sign Abnormalities
Time frame: 30 months
Growth Factor Support
Time frame: 30 months
Eligibility criteria
Study locations (3)
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90404
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
References
- Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.(PubMed)
- Schmid P, Cortés J, Marmé F, Rugo HS, Tolaney SM, Oliveira M, Loirat D, Jhaveri K, Yoon OK, Motwani M, Wang H, Delaney RJ, Bardia A. Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study. Annals of Oncology. 2022; 33(Suppl7): S635-636.