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PREDIX II HER2 :
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Kornalijnslijper-Altena, Renske
(author)
PREDIX II HER2 : Improving pre-operative systemic therapy for human epidermal growth factor receptor 2 (HER2) amplified breast cancer (BC)
- Article/chapterEnglish2020
Publisher, publication year, extent ...
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American Society of Clinical Oncology,2020
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LIBRIS-ID:oai:DiVA.org:oru-90313
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-90313URI
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https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS605DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:vet swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Funding Agency:Pharmaceutical/Biotech Company
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Background: Neo-adjuvant systemic therapy (NAT) is the standard of care for most patients with early HER2-amplified and triple negative breast cancer (BC). Increasing the rate of pathological complete response (pCR) is highly meaningful for those patients, as pCR is strongly predictive for improved long-term disease-related outcomes. Clinical and preclinical evidence support the hypothesis that pCR-rates may be augmented by the addition of checkpoint inhibitors, such as monoclonal antibodies targeting the Programmed Death Ligand receptor 1 (PD-L1), to standard systemic NAT. Studies in different BC patient cohorts (e.g., IMPassion130, PANACEA, KATE2) have indicated that PD-L1 protein expression on tumor-infiltrating lymphocytes (TIL’s) is a predictive marker for checkpoint inhibitor efficacy.Methods: We have initiated a phase II open-label, 2:1 randomized clinical trial where women with early HER2-amplified, PD-L1+ BC (cT2-3 and/or cN+) are treated with standard NAT (composed of anti-HER2 antibodies with a chemotherapy backbone of sequentially taxanes + carboplatin and epirubicin + cyclophosphamide [EC]) +/- atezolizumab during EC. N = 190 patients will be accrued in nine centers in Sweden to be able to demonstrate a 20% increase in pCR-rate, with a power of 80% and a two-sided alpha of 10%. Firstly, a prescreening is performed to select patients with a PD-L1 expression of > 1% on TIL’s. Important exclusion criteria are significant organ dysfunction and (with some exceptions) active auto-immune diseases. Extensive translational side-studies are performed to explore predictive markers for treatment efficacy, including clinicopathologic studies, molecular imaging and microbiome analyses, as well as monitoring of acute and chronic treatment-related toxicity, objective cognitive function and quality of life. As of February 11th, 4 patients have been prescreened and 1 enrolled in the trial. The clinical trial registry number is NCT03894007.
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Andersson, Anne
(author)
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Brandberg, Yvonne
(author)
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Kessler, Luisa Edman
(author)
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Elinder, Ellinor
(author)
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Hartman, Johan
(author)
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Hellstrom, Mats
(author)
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Johansson, Hemming
(author)
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Killander, Fredrika
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Linderholm, Barbro Kristina
(author)
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Lindman, Henrik
(author)
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Valachis, Antonis,1984-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län(Swepub:oru)asvs
(author)
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Wennstig, Anna Karin
(author)
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Xie, Hanjing
(author)
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Hatschek, Thomas
(author)
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Bergh, Jonas C. S.
(author)
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Örebro universitetInstitutionen för medicinska vetenskaper
(creator_code:org_t)
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In:Journal of Clinical Oncology: American Society of Clinical Oncology38:15 Suppl.0732-183X1527-7755
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Andersson, Anne
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Elinder, Ellinor
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Hartman, Johan
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Hellstrom, Mats
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Wennstig, Anna K ...
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Xie, Hanjing
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