Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors

Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors

Copyright © 2019. Published by Elsevier Inc.

Bibliographische Detailangaben
Veröffentlicht in:Clinical immunology (Orlando, Fla.). - 1999. - 201(2019) vom: 20. Apr., Seite 48-54
1. Verfasser: Clifton, G Travis (VerfasserIn)
Weitere Verfasser: Peace, Kaitlin M, Holmes, Jarrod P, Vreeland, Timothy J, Hale, Diane F, Herbert, Garth S, Litton, Jennifer K, Murthy, Rashmi K, Lukas, Jason, Peoples, George E, Mittendorf Elizabeth, A
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2019
Zugriff auf das übergeordnete Werk:Clinical immunology (Orlando, Fla.)
Schlagworte:Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S. Breast cancer HER2 Monoclonal antibody Peptide vaccine mehr... Trastuzumab Antineoplastic Agents, Immunological HER2 peptide (369-377) Immunologic Factors Peptide Fragments Granulocyte-Macrophage Colony-Stimulating Factor 83869-56-1 Receptor, ErbB-2 EC 2.7.10.1 P188ANX8CK
Beschreibung
Zusammenfassung:Copyright © 2019. Published by Elsevier Inc.
The development of HER2-targeted therapy has decreased recurrence rates and improved survival, transforming the natural history of HER2-positive breast cancer. However only a minority of breast cancer patients benefit as these agents are not used in patients with tumors expressing low levels of HER2. Preclinical data suggests a synergistic action of HER2-targeted vaccination with trastuzumab. We report the initial safety interim analysis of a phase II trial that enrolled patients with HER2 low-expressing (IHC 1+/2+) breast cancer who were clinically disease-free after standard therapy. Patients were randomized to receive the HER2-peptide vaccine nelipepimut-S + GM-CSF with trastuzumab (vaccine arm) or trastuzumab + GM-CSF (control arm) and were followed for recurrence. A planned analysis that occurred after enrollment of 150 patients showed no significant differences in toxicity between the two arms, including cardiac toxicity. The clinical efficacy of this combination will be reported 6 months after the final patient was enrolled
Beschreibung:Date Completed 21.01.2020
Date Revised 21.01.2020
published: Print-Electronic
Citation Status MEDLINE
ISSN:1521-7035
DOI:10.1016/j.clim.2019.02.011