Trodelvy 200 mg powder for concentrate for solution for infusion.
Sponsors
Unicancer, Gilead Sciences Inc.
Conditions
Locally advanced or metastatic hormone receptor (HR)-positiveTriple negative metastatic breast cancerhuman epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who have received an endocrine-based regimen
Phase 3
ISIdE: Open label, multicentric, single-arm phase IIIB trial to evaluate the safety and efficacy of sacituzumab govitecan in triple negative metastatic breast cancer patients with a biomarker analysis.
RecruitingCTIS2022-502369-10-00
Start: 2023-10-02Target: 48Updated: 2025-04-25
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Active, not recruitingCTIS2022-502593-17-00
Start: 2023-09-19Target: 428Updated: 2025-11-24