Sökning: id:"swepub:oai:DiVA.org:oru-90313" >
PREDIX II HER2 :
-
Kornalijnslijper-Altena, Renske
(författare)
PREDIX II HER2 : Improving pre-operative systemic therapy for human epidermal growth factor receptor 2 (HER2) amplified breast cancer (BC)
- Artikel/kapitelEngelska2020
Förlag, utgivningsår, omfång ...
-
American Society of Clinical Oncology,2020
-
printrdacarrier
Nummerbeteckningar
-
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
Kompletterande språkuppgifter
-
Språk:engelska
-
Sammanfattning på:engelska
Ingår i deldatabas
Klassifikation
-
Ämneskategori:vet swepub-contenttype
-
Ämneskategori:art swepub-publicationtype
Anmärkningar
-
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.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
-
Andersson, Anne
(författare)
-
Brandberg, Yvonne
(författare)
-
Kessler, Luisa Edman
(författare)
-
Elinder, Ellinor
(författare)
-
Hartman, Johan
(författare)
-
Hellstrom, Mats
(författare)
-
Johansson, Hemming
(författare)
-
Killander, Fredrika
(författare)
-
Linderholm, Barbro Kristina
(författare)
-
Lindman, Henrik
(författare)
-
Valachis, Antonis,1984-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län(Swepub:oru)asvs
(författare)
-
Wennstig, Anna Karin
(författare)
-
Xie, Hanjing
(författare)
-
Hatschek, Thomas
(författare)
-
Bergh, Jonas C. S.
(författare)
-
Örebro universitetInstitutionen för medicinska vetenskaper
(creator_code:org_t)
Sammanhörande titlar
-
Ingår i:Journal of Clinical Oncology: American Society of Clinical Oncology38:15 Suppl.0732-183X1527-7755
Internetlänk
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Kornalijnslijper ...
-
Andersson, Anne
-
Brandberg, Yvonn ...
-
Kessler, Luisa E ...
-
Elinder, Ellinor
-
Hartman, Johan
-
visa fler...
-
Hellstrom, Mats
-
Johansson, Hemmi ...
-
Killander, Fredr ...
-
Linderholm, Barb ...
-
Lindman, Henrik
-
Valachis, Antoni ...
-
Wennstig, Anna K ...
-
Xie, Hanjing
-
Hatschek, Thomas
-
Bergh, Jonas C. ...
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Cancer och onkol ...
- Artiklar i publikationen
-
Journal of Clini ...
- Av lärosätet
-
Örebro universitet