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PREDIX II HER2 :
PREDIX II HER2 : Improving pre-operative systemic therapy for human epidermal growth factor receptor 2 (HER2) amplified breast cancer (BC)
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Kornalijnslijper-Altena, Renske (författare)
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Andersson, Anne (författare)
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Brandberg, Yvonne (författare)
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Kessler, Luisa Edman (författare)
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Elinder, Ellinor (författare)
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Hartman, Johan (författare)
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Hellstrom, Mats (författare)
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Johansson, Hemming (författare)
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Killander, Fredrika (författare)
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Linderholm, Barbro Kristina (författare)
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Lindman, Henrik (författare)
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- Valachis, Antonis, 1984- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län
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Wennstig, Anna Karin (författare)
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Xie, Hanjing (författare)
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Hatschek, Thomas (författare)
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Bergh, Jonas C. S. (författare)
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(creator_code:org_t)
- American Society of Clinical Oncology, 2020
- 2020
- Engelska.
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Ingår i: Journal of Clinical Oncology. - : American Society of Clinical Oncology. - 0732-183X .- 1527-7755. ; 38:15 Suppl.
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Kornalijnslijper ...
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Andersson, Anne
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Brandberg, Yvonn ...
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Kessler, Luisa E ...
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Elinder, Ellinor
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Hartman, Johan
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visa fler...
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Hellstrom, Mats
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Johansson, Hemmi ...
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Killander, Fredr ...
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Linderholm, Barb ...
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Lindman, Henrik
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Valachis, Antoni ...
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Wennstig, Anna K ...
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Xie, Hanjing
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Hatschek, Thomas
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Bergh, Jonas C. ...
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visa färre...
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Örebro universitet