RT Journal Article
T1 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.
A1 Pascual, Tomás
A1 Oliveira, Mafalda
A1 Ciruelos, Eva
A1 Bellet Ezquerra, Meritxell
A1 Saura, Cristina
A1 Gavilá, Joaquin
A1 Pernas, Sonia
A1 Muñoz, Montserrat
A1 Vidal, Maria J
A1 Margelí Vila, Mireia
A1 Cejalvo, Juan M
A1 González-Farré, Blanca
A1 Espinosa-Bravo, Martin
A1 Cruz, Josefina
A1 Salvador-Bofill, Francisco Javier
A1 Guerra, Juan Antonio
A1 Luna Barrera, Ana María
A1 Arumi de Dios, Miriam
A1 Esker, Stephen
A1 Fan, Pang-Dian
A1 Martínez-Sáez, Olga
A1 Villacampa, Guillermo
A1 Paré, Laia
A1 Ferrero-Cafiero, Juan M
A1 Villagrasa, Patricia
A1 Prat, Aleix
K1 Breast Cancer
K1 CelTIL Score
K1 ERBB3
K1 HER3
K1 HER3-DXd
K1 U3-1402
K1 patritumab deruxtecan
AB 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. Trial Registration Number: EudraCT 2019-004964-23; NCT number: NCT04610528.
SN 2234-943X
YR 2021
FD 2021-04-23
LK https://hdl.handle.net/10668/27194
UL https://hdl.handle.net/10668/27194
LA en
DS RISalud
RD Apr 5, 2025