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Efficacy and Safety of Sacituzumab Govitecan for Breast Cancer

Lance G. Tolentino, Marharyta Khaustova, Reham Z. Alrwaitey, Asiya S. Chintala and 7 more

American Journal of Clinical Oncology | Sep 9, 2026

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The meta-analysis shows that sacituzumab govitecan significantly improves PFS, OS, and ORR compared with standard chemotherapy in patients with HER2-negative breast cancer, reinforcing the role of SG as an effective treatment option for both metastatic TNBC and HR+/HER2- breast cancer.

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OBJECTIVES: Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, has demonstrated clinical activity in HER2-negative breast cancer. Our meta-analysis aimed to evaluate the efficacy and safety of SG compared with standard chemotherapy in patients with breast cancer. METHODS: We conducted a comprehensive literature search across multiple databases for RCTs comparing SG with standard treatment in patients with breast cancer. The primary outcomes were progression-free survival (PFS) and overall survival (OS). Secondary outcomes included objective response rate (ORR), clinical benefit rate (CBR), disease control measures, and treatment-related adverse events. Hazard ratios (HRs), mean differences (MDs), and risk ratios (RRs) with 95% CIs were pooled using a random-effects model. RESULTS: Six RCTs encompassing 2481 patients were included. SG significantly improved PFS (HR=0.59), OS (HR=0.63), and ORR (RR=1.64) compared with chemotherapy. CBR was also significantly higher with SG (RR=1.89), and the rate of progressive disease was significantly lower (RR=0.62). Overall treatment-related adverse events were similar in both groups (RR=1.05). Neutropenia and diarrhea were significantly more frequent in the SG group. CONCLUSIONS: Our meta-analysis shows that sacituzumab govitecan significantly improves PFS, OS, and ORR compared with standard chemotherapy in patients with HER2-negative breast cancer. Although associated with higher rates of neutropenia and diarrhea, its overall safety profile remains manageable. These results reinforce the role of SG as an effective treatment option for both metastatic TNBC and HR+/HER2- breast cancer and support its continued evaluation in earlier treatment settings and combination strategies, including immunotherapy.

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Authors

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Lance G. Tolentino

first | Ateneo de Manila University

Marharyta Khaustova

middle | Kharkiv National Medical University

Reham Z. Alrwaitey

middle | King Saud University

Asiya S. Chintala

middle | International Teaching University of Georgia

Debasrita Baidya

middle | University College London

Vutukuri Y. Kumar

middle | International Teaching University of Georgia

Dalal Abdelrahim

middle | University of Medical Sciences and Technology

Nnenna S.S. Ejiogu

middle | Regional Medical Center

Vanshika Bhardwaj

middle | Lancashire Teaching Hospitals NHS Foundation Trust

Breman A. Peethambar

middle | University of Florida

Muhammad Ayyan

last | King Edward Medical University | ORCID 0009-0002-6298-5987

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BibTeX

@article{Tolentino2026Efficacy,
  title = {Efficacy and Safety of Sacituzumab Govitecan for Breast Cancer},
  author = {Lance G. Tolentino and Marharyta Khaustova and Reham Z. Alrwaitey and Asiya S. Chintala and Debasrita Baidya and Vutukuri Y. Kumar and Dalal Abdelrahim and Nnenna S.S. Ejiogu and Vanshika Bhardwaj and Breman A. Peethambar and Muhammad Ayyan},
  journal = {American Journal of Clinical Oncology},
  year = {2026},
  doi = {10.1097/coc.0000000000001365},
  url = {https://doi.org/10.1097/coc.0000000000001365}
}

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