Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Apr 22;384(16):1529-1541.
doi: 10.1056/NEJMoa2028485.

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

Aditya Bardia  1 , Sara A Hurvitz  1 , Sara M Tolaney  1 , Delphine Loirat  1 , Kevin Punie  1 , Mafalda Oliveira  1 , Adam Brufsky  1 , Sagar D Sardesai  1 , Kevin Kalinsky  1 , Amelia B Zelnak  1 , Robert Weaver  1 , Tiffany Traina  1 , Florence Dalenc  1 , Philippe Aftimos  1 , Filipa Lynce  1 , Sami Diab  1 , Javier Cortés  1 , Joyce O'Shaughnessy  1 , Véronique Diéras  1 , Cristiano Ferrario  1 , Peter Schmid  1 , Lisa A Carey  1 , Luca Gianni  1 , Martine J Piccart  1 , Sibylle Loibl  1 , David M Goldenberg  1 , Quan Hong  1 , Martin S Olivo  1 , Loretta M Itri  1 , Hope S Rugo  1 ; ASCENT Clinical Trial Investigators
Collaborators, Affiliations
Clinical Trial

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

Aditya Bardia et al. N Engl J Med. .

Abstract

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.).

PubMed Disclaimer

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

Publication types

MeSH terms

Associated data