Sequencing of Antibody Drug Conjugates in ER+/HER2 LOW Metastatic Breast Cancer (SERIES trial)
A new Phase 2 ISR (Miami Cancer Institute) SERIES (SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer) was listed evaluating Trodelvy after T-DXd (Enhertu, HER2-ADC) in heavily pre-treated HR+/HER2-low mBC (N=75; SSD: Apr 2024; PCD: Apr 2026; SCD: Oct 2026)
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.
- Patients are eligible after the following prior treatments:
- At least 1 line of ET
- At least 1 line of CDK4/6i +/- ET
- 1-4 lines of chemo
- T-DXd
- Primary outcome is ORR
- Secondary outcomes include CBR, PFS, OS, DOR, QoL, and AEs
- As ADCs advance into earlier LoT and sequential use of ADC becomes more common, additional data is needed to better understand ADC resistance, as well as optimal ADC administration order
- This study could provide some initial clinical data on the sequencing of ADCs with varying ADC target and payload
- Sequential use of Dato-DXd (TROP2-ADC) after T-DXd is also being evaluated in the TRADE-DXd trial (unlisted)