A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors

@article{Limentani2016AND,
  title={A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors},
  author={Steven A. Limentani and Mario Campone and Thierry Dorval and Giuseppe Curigliano and Richard de Boer and C. Vogel and Shane D. White and Thomas Bachelot and J. L. Canon and Mary Disis and Ahmad Awada and Martine Berli{\`e}re and Fr{\'e}d{\'e}ric Amant and Ellis Levine and Wivine Burny and Andrea Callegaro and Pedro Miguel de Sousa Alves and Jamila Louahed and Vincent G Brichard and Fr{\'e}d{\'e}ric F. Lehmann},
  journal={Breast Cancer Research and Treatment},
  year={2016},
  volume={156},
  pages={319-330}
}
This Phase I dose-escalation study (NCT00058526) assessed the safety and immunogenicity of an anti-cancer immunotherapeutic (recombinant HER2 protein (dHER2) combined with the immunostimulant AS15) in patients with early-stage HER2-overexpressing breast cancer (BC). Sixty-one trastuzumab-naive patients with stage II–III HER2-positive BC received the dHER2 immunotherapeutic after surgical resection and adjuvant therapy. They were allocated into four cohorts receiving different doses of dHER2 (20… CONTINUE READING
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