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
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100 1 |a Clifton, G Travis  |e verfasserin  |4 aut 
245 1 0 |a 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 
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520 |a Copyright © 2019. Published by Elsevier Inc. 
520 |a 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 
650 4 |a Clinical Trial, Phase II 
650 4 |a Journal Article 
650 4 |a Randomized Controlled Trial 
650 4 |a Research Support, N.I.H., Extramural 
650 4 |a Research Support, Non-U.S. Gov't 
650 4 |a Research Support, U.S. Gov't, Non-P.H.S. 
650 4 |a Breast cancer 
650 4 |a HER2 
650 4 |a Monoclonal antibody 
650 4 |a Peptide vaccine 
650 4 |a Trastuzumab 
650 7 |a Antineoplastic Agents, Immunological  |2 NLM 
650 7 |a HER2 peptide (369-377)  |2 NLM 
650 7 |a Immunologic Factors  |2 NLM 
650 7 |a Peptide Fragments  |2 NLM 
650 7 |a Granulocyte-Macrophage Colony-Stimulating Factor  |2 NLM 
650 7 |a 83869-56-1  |2 NLM 
650 7 |a Receptor, ErbB-2  |2 NLM 
650 7 |a EC 2.7.10.1  |2 NLM 
650 7 |a Trastuzumab  |2 NLM 
650 7 |a P188ANX8CK  |2 NLM 
700 1 |a Peace, Kaitlin M  |e verfasserin  |4 aut 
700 1 |a Holmes, Jarrod P  |e verfasserin  |4 aut 
700 1 |a Vreeland, Timothy J  |e verfasserin  |4 aut 
700 1 |a Hale, Diane F  |e verfasserin  |4 aut 
700 1 |a Herbert, Garth S  |e verfasserin  |4 aut 
700 1 |a Litton, Jennifer K  |e verfasserin  |4 aut 
700 1 |a Murthy, Rashmi K  |e verfasserin  |4 aut 
700 1 |a Lukas, Jason  |e verfasserin  |4 aut 
700 1 |a Peoples, George E  |e verfasserin  |4 aut 
700 1 |a Mittendorf Elizabeth, A  |e verfasserin  |4 aut 
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