Treating Advanced Triple Negative Breast Cancer with Sacituzumab Govitecan
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on December 8th, 2025
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Patients with breast tumors that lack expression of the three major hormone receptors face poorer outcomes than others. These triple-negative breast cancers have a 5-year case-fatality rate of roughly 85%. Although blocking the PD-1 immune-evasion pathway can be effective, such immunotherapies offer little benefit when tumors do not express or downregulate PD-1. To address this challenge, a Gilead-funded study evaluated sacituzumab govitecan as a treatment option for triple-negative breast cancer.
The phase 3 trial enrolled 558 women with a median age of 55. All participants had tumors confirmed to express less than 1% of estrogen receptor, progesterone receptor, and HER2. Only three patients had tumors expressing PD-L1. About 30% presented with metastatic disease at diagnosis, while the remainder had recurrence after earlier treatment.
Participants were randomly assigned to receive standard chemotherapy-paclitaxel, carboplatin, or gemcitabine-or sacituzumab govitecan. The investigational therapy was administered intravenously at 10 mg per kilogram on days 1 and 8 of a 21-day cycle. Sacituzumab govitecan is an antibody–drug conjugate: its antibody component targets Trop-2, a surface antigen frequently overexpressed in TNBC, while the linked drug is a topoisomerase I inhibitor that disrupts DNA replication and limits tumor cell proliferation.
Sacituzumab govitecan markedly improved outcomes. Median progression-free survival increased to 9.7 months, compared with 6.9 months in the chemotherapy group, corresponding to a 38% reduction in the risk of disease progression or death. Subgroup analyses indicated that treatment was most effective in patients younger than 65, without brain metastases, and with prior exposure to paclitaxel. Common adverse events included neutropenia, diarrhea, and leukopenia.
The phase 3 trial enrolled 558 women with a median age of 55. All participants had tumors confirmed to express less than 1% of estrogen receptor, progesterone receptor, and HER2. Only three patients had tumors expressing PD-L1. About 30% presented with metastatic disease at diagnosis, while the remainder had recurrence after earlier treatment.
Participants were randomly assigned to receive standard chemotherapy-paclitaxel, carboplatin, or gemcitabine-or sacituzumab govitecan. The investigational therapy was administered intravenously at 10 mg per kilogram on days 1 and 8 of a 21-day cycle. Sacituzumab govitecan is an antibody–drug conjugate: its antibody component targets Trop-2, a surface antigen frequently overexpressed in TNBC, while the linked drug is a topoisomerase I inhibitor that disrupts DNA replication and limits tumor cell proliferation.
Sacituzumab govitecan markedly improved outcomes. Median progression-free survival increased to 9.7 months, compared with 6.9 months in the chemotherapy group, corresponding to a 38% reduction in the risk of disease progression or death. Subgroup analyses indicated that treatment was most effective in patients younger than 65, without brain metastases, and with prior exposure to paclitaxel. Common adverse events included neutropenia, diarrhea, and leukopenia.