drugset / Trial / NCT04639986
Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.
Timeline
- Start
- 2020-11-23
- Primary completion
- 2026-12
- Completion
- 2026-12
Outcome
Met primary endpoint
paper The primary endpoint was met: PFS was improved with SG versus chemotherapy PMID 39354196 ↗
paper hazard ratio of 0.67, 95% confidence interval 0.52-0.87; P = 0.0028 PMID 39354196 ↗
Publications
- Xu B, Wang S, Yan M, Sohn J, Li W, Tang J, Wang X, Wang Y, Im SA, Jiang D, Valdez T, Dasgupta A, Zhang Y, Yan Y, Komatsubara KM, Chung WP, Ma F, Dai MS. Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nat Med. 2024 Dec;30(12):3709-3716. doi: 10.1038/s41591-024-03269-z. Epub 2024 Oct 1.
- Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Eribulin | Small molecule | 1.23 mg/m2 | Intravenous |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |