Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer
Open accessAbstract
BACKGROUND: Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan is an antibody-drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 (topoisomerase I inhibitor) through a proprietary hydrolyzable linker. METHODS: In this randomized, phase 3 trial, we evaluated sacituzumab govitecan as compared with single-agent chemotherapy of the physician's choice (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with relapsed or refractory metastatic triple-negative breast cancer. The primary end point was progression-free survival (as determined by blinded independent central review) among patients without brain metastases. RESULTS: A total of 468 patients without brain metastases were randomly assigned to receive sacituzumab govitecan (235 patients) or chemotherapy (233 patients). The median age was 54 years; all the patients had previous use of taxanes. The median progression-free survival was 5.6 months (95% confidence interval [CI], 4.3 to 6.3; 166 events) with sacituzumab govitecan and 1.7 months (95% CI, 1.5 to 2.6; 150 events) with chemotherapy (hazard ratio for disease progression or death, 0.41; 95% CI, 0.32 to 0.52; P<0.001). The median overall survival was 12.1 months (95% CI, 10.7 to 14.0) with sacituzumab govitecan and 6.7 months (95% CI, 5.8 to 7.7) with chemotherapy (hazard ratio for death, 0.48; 95% CI, 0.38 to 0.59; P<0.001). The percentage of patients with an objective response was 35% with sacituzumab govitecan and 5% with chemotherapy. The incidences of key treatment-related adverse events of grade 3 or higher were neutropenia (51% with sacituzumab govitecan and 33% with chemotherapy), leukopenia (10% and 5%), diarrhea (10% and <1%), anemia (8% and 5%), and febrile neutropenia (6% and 2%). There were three deaths owing to adverse events in each group; no deaths were considered to be related to sacituzumab govitecan treatment. CONCLUSIONS: Progression-free and overall survival were significantly longer with sacituzumab govitecan than with single-agent chemotherapy among patients with metastatic triple-negative breast cancer. Myelosuppression and diarrhea were more frequent with sacituzumab govitecan. (Funded by Immunomedics; ASCENT ClinicalTrials.gov number, NCT02574455; EudraCT number, 2017-003019-21.).
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The TROP2-targeted antibody-drug conjugates sacituzumab govitecan and datopotamab deruxtecan showed promising clinical efficacy in several cancer entities, including locally advanced or metastatic triple-negative breast cancer, hormone receptor-positive and HER2-negative breast cancer, and locally advanced or metastatic urothelial carcinoma.
“The TROP2-targeted ADCs sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) showed promising clinical efficacy in several cancer entities, including locally advanced or metastatic triple-negative breast cancer,84 hormone receptor-positive and HER2-negative breast cancer85 and locally advanced or metastatic urothelial carcinoma.86”
From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [84]
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- Authors
- Bardia, A., Hurvitz, S. A., Tolaney, S. M., Loirat, D., Punie, K., Oliveira, M., Brufsky, A., Sardesai, S. D., Kalinsky, K., Zelnak, A. B., Weaver, R., Traina, T., Dalenc, F., Aftimos, P., Lynce, F., Diab, S., Cortés, J., O’Shaughnessy, J., Diéras, V., Ferrario, C., Schmid, P., Carey, L. A., Gianni, L., Piccart, M. J., Loibl, S., Goldenberg, D. M., Hong, Q., Olivo, M. S., Itri, L. M., & Rugo, H. S.
- Affiliations
- Université Libre de Bruxelles (BE)
- Northside Hospital (US)
- From the Division of Medical Oncology, Massachusetts General Hospital Cancer Center (A. Bardia), and the Department of Medical Oncology, Dana–Farber Cancer Institute (S.M.T.) — both in Boston; the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); the Medical Oncology Department and the Department of Drug Development and Innovation, Institut Curie, Paris (D.L.), Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse (F.D.), and the Department of Medical Oncology, Centre Eugène Marquis, Rennes (V.D.) — all in France; the Department of General Medical Oncology and Multidisciplinary Breast Center, Leuven Cancer Institute, University Hospitals Leuven, Leuven (K.P.), and the Clinical Trials Conduct Unit (P.A.), Institut Jules Bordet–Université Libre de Bruxelles (M.J.P.), Brussels — all in Belgium; the Medical Oncology Department and Breast Cancer Group, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (M....
- ORCID
- Bardia, Aditya
- Hurvitz, Sara A.
- Tolaney, Sara M.
- Punie, Kevin
- Oliveira, Mafalda
- Brufsky, Adam
- Sardesai, Sagar D.
- Kalinsky, Kevin
- Traina, Tiffany
- Dalenc, Florence
- Aftimos, Philippe
- Lynce, Filipa
- Cortés, Javier
- O’Shaughnessy, Joyce
- Ferrario, Cristiano
- Schmid, Peter
- Gianni, Luca
- Piccart, Martine J.
- Loibl, Sibylle
- Goldenberg, David M.
- Rugo, Hope S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-04-22
- Volume
- 384
- Issue
- 16
- Pages
- 1529-1541
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3156985612
- Cited by
- 1,711
- References
- 30
- Citations by year
- 2026: 378 · 2025: 392 · 2024: 345 · 2023: 305 · 2022: 222 · 2021: 68
- FWCI
- 93.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- UNC Libraries
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
- Keywords
- sacituzumab govitecan, metastatic triple-negative breast cancer, antibody-drug conjugates, TROP2, SN-38, topoisomerase I inhibitor, progression-free survival, overall survival, single-agent chemotherapy, neutropenia, diarrhea, treatment-related adverse events, objective response rate, brain metastases, taxane-refractory disease
- MeSH terms
- Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antigens, Neoplasm, Antineoplastic Agents, Camptothecin, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Cell Adhesion Molecules, Survival Analysis, Immunoconjugates, Drug Resistance, Neoplasm, Tumor Burden, Antibodies, Monoclonal, Humanized, Triple Negative Breast Neoplasms
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