SOLTI-1805 TOT-HER3 Study Concept: A Window-of-Opportunity Trial of Patritumab Deruxtecan, a HER3 Directed Antibody Drug Conjugate, in Patients With Early Breast Cancer
| العنوان: | SOLTI-1805 TOT-HER3 Study Concept: A Window-of-Opportunity Trial of Patritumab Deruxtecan, a HER3 Directed Antibody Drug Conjugate, in Patients With Early Breast Cancer |
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| المؤلفون: | Tomás Pascual, Mafalda Oliveira, Eva Ciruelos, Meritxell Bellet Ezquerra, Cristina Saura, Joaquin Gavilá, Sonia Pernas, Montserrat Muñoz, Maria J. Vidal, Mireia Margelí Vila, Juan M. Cejalvo, Blanca González-Farré, Martin Espinosa-Bravo, Josefina Cruz, Francisco Javier Salvador-Bofill, Juan Antonio Guerra, Ana María Luna Barrera, Miriam Arumi de Dios, Stephen Esker, Pang-Dian Fan, Olga Martínez-Sáez, Guillermo Villacampa, Laia Paré, Juan M. Ferrero-Cafiero, Patricia Villagrasa, Aleix Prat |
| المساهمون: | Servicio de Oncología. Hospital Universitario de Fuenlabrada, Institut Català de la Salut, [Pascual T] SOLTI Innovative Cancer Research, Barcelona, Spain. Medical Oncology Department, Hospital Clinic de Barcelona, Barcelona, Spain. Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (Instituto de Investigaciones Biomédicas August Pi i Sunyer), Barcelona, Spain. [Oliveira M, Bellet Ezquerra M, Saura C] SOLTI Innovative Cancer Research, Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Breast Cancer Program, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ciruelos E] SOLTI Innovative Cancer Research, Barcelona, Spain. Medical Oncology Department, Hospital 12 de Octubre, Madrid, Spain. [Gavilá J] SOLTI Innovative Cancer Research, Barcelona, Spain. Medical Oncology Department, IVO—Fundación Instituto Valenciano de Oncología, Valencia, Spain. [Espinosa-Bravo M] Unitat de Cirurgia de Càncer de Mama, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Arumi de Dios M] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Dipòsit Digital de la UB Universidad de Barcelona Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid Frontiers in Oncology r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname Frontiers in Oncology, Vol 11 (2021) r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA Scientia |
| بيانات النشر: | Frontiers Media S. A., 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | 0301 basic medicine, Oncology, Cancer Research, Patritumab, Antibody-drug conjugate, medicine.medical_specialty, patritumab deruxtecan, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Translational research, Drug resistance, Hormone receptors, Other subheadings::Other subheadings::/drug therapy [Other subheadings], CelTIL Score, HER3-DXd, Càncer de mama, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Investigative Techniques::Investigative Techniques::Evaluation Studies as Topic::Drug Evaluation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], HER3, Internal medicine, Medicaments - Assaigs clínics, Hypothesis and Theory, Breast Cancer, Clinical endpoint, medicine, ERBB3, skin and connective tissue diseases, RC254-282, Tumor microenvironment, neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], Models, Statistical, Receptors d'hormones, business.industry, Modelos Estadísticos, Neoplasias de la Mama, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, 030104 developmental biology, 030220 oncology & carcinogenesis, Mama - Càncer - Tractament, U3-1402, técnicas de investigación::técnicas de investigación::estudios de evaluación como asunto::evaluación de medicamentos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Breast neoplasms, business |
| الوصف: | Càncer de mama; Puntuació CelTIL; Patritumab deruxtecan Cáncer de mama; Puntuación CelTIL; Patritumab deruxtecan Breast Cancer; CelTIL Score; Patritumab deruxtecan Background: Preclinical data support a key role for the human epidermal growth factor receptor 3 (HER3) pathway in hormone receptor (HR)–positive breast cancer. Recently, new HER3 directed antibody drug conjugates have shown activity in breast cancer. Given the need to better understand the molecular biology, tumor microenvironment, and mechanisms of drug resistance in breast cancer, we designed this window-of-opportunity study with the HER3 directed antibody drug conjugate patritumab deruxtecan (HER3-DXd; U3-1402). Trial Design: Based on these data, a prospective, multicenter, single-arm, window-of-opportunity study was designed to evaluate the biological effect of patritumab deruxtecan in the treatment of naïve patients with HR-positive/HER2-negative early breast cancer whose primary tumors are ≥1 cm by ultrasound evaluation. Patients will be enrolled in four cohorts according to the mRNA-based ERBB3 expression by central assessment. The primary endpoint is a CelTIL score after one single dose. A translational research plan is also included to provide biological information and to evaluate secondary and exploratory objectives of the study. We thank Daiichi Sankyo for their provision of patritumab deruxtecan and their financial contribution to this clinical study. Pas a Pas and Save the Mama to AP. Fundación SEOM (SEOM 2018 Grant: Fellowship for Training in Research in Reference Centers) to TP. |
| وصف الملف: | application/pdf |
| تدمد: | 2234-943X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1daac2f036bf4a3078a12492554c1412 http://hdl.handle.net/2445/177728 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....1daac2f036bf4a3078a12492554c1412 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 2234943X |
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