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Peer-reviewedCC BY 4.0Cancers

Efficacy and Safety of Monoclonal Antibodies in the Treatment of HER2-Positive Breast Cancer: A Systematic Review

  1. 1Department of Pharmacology, Physiology and Legal and Forensic Medicine, Faculty of Medicine, University of Zaragoza, 50009 Zaragoza, Spain
  2. 2Research Network on Global Evidence on Drug Regulation and Safety (GEDRAS), Institute for Health Research Aragón, Faculty of Medicine, University of Zaragoza, 50009 Zaragoza, Spain

Abstract

Background/Objectives: HER2-positive breast cancer is one of the most aggressive subtypes of breast cancer, characterised by overexpression of the HER2 receptor, which promotes tumour proliferation and is associated with a poorer clinical prognosis. The introduction of targeted therapies based on monoclonal antibodies has brought about a significant change in the management of the disease, improving survival and disease control. However, the efficacy and safety of some of these treatments remain under investigation. The aim was to evaluate the efficacy and safety of monoclonal antibodies in adult patients with HER2-positive breast cancer compared with placebo or any other drug, with both treatment and control groups receiving other anticancer therapies. Methods: A systematic review of the scientific literature was conducted, based on phase III, randomized, controlled, double-blind clinical trials published between 2020 and 2026 in the PubMed, Cochrane and Scopus databases. The review was carried out following the PICO framework and the PRISMA guidelines. Results: Eight reports of seven clinical trials were included, evaluating four monoclonal antibodies: pertuzumab, denosumab, atezolizumab and bevacizumab. Treatment with pertuzumab showed a significant improvement in tumour response and progression-free survival with an acceptable safety profile. In contrast, bevacizumab, denosumab and atezolizumab did not show significant clinical benefits and, furthermore, were associated with a higher incidence of adverse effects. Conclusions: Pertuzumab is an effective therapeutic strategy for the treatment of HER2-positive breast cancer. However, individualised treatment selection and appropriate monitoring of adverse effects are necessary.

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BibTeX
@article{alfaromunoz2026efficacy,
  title = {{Efficacy and Safety of Monoclonal Antibodies in the Treatment of HER2-Positive Breast Cancer: A Systematic Review}},
  author = {Lucía Alfaro-Muñoz and Ana Avedillo-Salas and Jorge Vicente-Romero and Ana Fanlo-Villacampa},
  journal = {Cancers},
  year = {2026},
  month = nov,
  doi = {10.3390/cancers18213577},
  url = {https://www.mdpi.com/2072-6694/18/21/3577},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy and Safety of Monoclonal Antibodies in the Treatment of HER2-Positive Breast Cancer: A Systematic Review
AU  - Lucía Alfaro-Muñoz
AU  - Ana Avedillo-Salas
AU  - Jorge Vicente-Romero
AU  - Ana Fanlo-Villacampa
PY  - 2026
DA  - 2026/11/06
JO  - Cancers
DO  - 10.3390/cancers18213577
UR  - https://www.mdpi.com/2072-6694/18/21/3577
AB  - Background/Objectives: HER2-positive breast cancer is one of the most aggressive subtypes of breast cancer, characterised by overexpression of the HER2 receptor, which promotes tumour proliferation and is associated with a poorer clinical prognosis. The introduction of targeted therapies based on monoclonal antibodies has brought about a significant change in the management of the disease, improving survival and disease control. However, the efficacy and safety of some of these treatments remain under investigation. The aim was to evaluate the efficacy and safety of monoclonal antibodies in adult patients with HER2-positive breast cancer compared with placebo or any other drug, with both treatment and control groups receiving other anticancer therapies. Methods: A systematic review of the scientific literature was conducted, based on phase III, randomized, controlled, double-blind clinical trials published between 2020 and 2026 in the PubMed, Cochrane and Scopus databases. The review was carried out following the PICO framework and the PRISMA guidelines. Results: Eight reports of seven clinical trials were included, evaluating four monoclonal antibodies: pertuzumab, denosumab, atezolizumab and bevacizumab. Treatment with pertuzumab showed a significant improvement in tumour response and progression-free survival with an acceptable safety profile. In contrast, bevacizumab, denosumab and atezolizumab did not show significant clinical benefits and, furthermore, were associated with a higher incidence of adverse effects. Conclusions: Pertuzumab is an effective therapeutic strategy for the treatment of HER2-positive breast cancer. However, individualised treatment selection and appropriate monitoring of adverse effects are necessary.
SN  - 2072-6694
ER  -