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Title: 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
Author: Pascual, Tomás
Oliveira, Mafalda
Ciruelos, Eva
Bellet Ezquerra, Meritxell
Saura, Cristina
Gavilá, Joaquin
Pernas, Sònia
Muñoz Mateu, Montserrat
Vidal Losada, Maria Jesús
Margelí Vila, Mireia
Cejalvo Andújar, Juan Miguel
González Farré, Blanca
Espinosa Bravo, Martin
Cruz, Josefina
Salvador Bofill, Francisco Javier
Guerra, Juan Antonio
Luna Barrera, Ana María
Arumi de Dios, Miriam
Esker, Stephen
Fan, Pang-dian
Martínez Sáez, Olga
Villacampa, Guillermo
Paré, Laia
Ferrero Cafiero, Juan M.
Villagrasa, Patricia
Prat Aparicio, Aleix
Keywords: Càncer de mama
Receptors d'hormones
Breast cancer
Hormone receptors
Issue Date: 23-Apr-2021
Publisher: Frontiers Media S. A.
Abstract: 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.
Note: Reproducció del document publicat a:
It is part of: Frontiers in Oncology, 2021
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Appears in Collections:Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Medicina)

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