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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 ...

  • American Society of Clinical Oncology,2020
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:oru-90313
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-90313URI
  • https://doi.org/10.1200/JCO.2020.38.15_suppl.TPS605DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:vet swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding Agency:Pharmaceutical/Biotech Company  
  • 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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Added entries (persons, corporate bodies, meetings, titles ...)

  • Andersson, Anne (author)
  • Brandberg, Yvonne (author)
  • Kessler, Luisa Edman (author)
  • Elinder, Ellinor (author)
  • Hartman, Johan (author)
  • Hellstrom, Mats (author)
  • Johansson, Hemming (author)
  • Killander, Fredrika (author)
  • Linderholm, Barbro Kristina (author)
  • Lindman, Henrik (author)
  • Valachis, Antonis,1984-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län(Swepub:oru)asvs (author)
  • Wennstig, Anna Karin (author)
  • Xie, Hanjing (author)
  • Hatschek, Thomas (author)
  • Bergh, Jonas C. S. (author)
  • Örebro universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

Related titles

  • In:Journal of Clinical Oncology: American Society of Clinical Oncology38:15 Suppl.0732-183X1527-7755

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