drugset / Trial / NCT03901339
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
Timeline
- Start
- 2019-05-08
- Primary completion
- 2023-10-20
- Completion
- 2023-10-20
Outcome
Met primary endpoint
registry Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC); p = 0.0001; Hazard Ratio (HR) 0.653 (95% CI 0.526 to 0.812) NCT03901339 ↗
release “Phase 3 TROPiCS-02 study of Trodelvy in patients with HR+/HER2- metastatic breast cancer who had been heavily pre-treated. The study met its primary endpoint” gilead.com ↗
release “The TROPiCS-02 study met its primary endpoint of progression-free survival earlier this year;” gilead.com ↗
Publications
- Background Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.
- Background Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.
- Background 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.
- Background Rugo HS, Schmid P, Tolaney SM, Dalenc F, Marme F, Shi L, Verret W, Shah A, Gharaibeh M, Bardia A, Cortes J. Health-related quality of life with sacituzumab govitecan in HR+/HER2- metastatic breast cancer in the phase III TROPiCS-02 trial. Oncologist. 2024 Sep 6;29(9):768-779. doi: 10.1093/oncolo/oyae088.
- Background Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Spears PA, Tolaney SM. A plain language summary of the TROPiCS-02 study in patients with breast cancer (HR-positive/HER2-negative). Future Oncol. 2024 Apr;20(11):635-651. doi: 10.2217/fon-2023-0845. Epub 2024 Jan 25.
- Background Rugo HS, Bardia A, Tolaney S. Sacituzumab govitecan for metastatic breast cancer: the TROPiCS-02 trial - Authors' reply. Lancet. 2024 Jul 27;404(10450):339-340. doi: 10.1016/S0140-6736(24)01049-3. No abstract available.
- McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.
- Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.
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 |