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

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, t...

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Published inFrontiers in oncology Vol. 11; p. 638482
Main Authors Pascual, Tomás, Oliveira, Mafalda, Ciruelos, Eva, Bellet Ezquerra, Meritxell, Saura, Cristina, Gavilá, Joaquin, Pernas, Sonia, Muñoz, Montserrat, Vidal, Maria J, Margelí Vila, Mireia, Cejalvo, Juan M, 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, Aleix
Format Journal Article
LanguageEnglish
Published Switzerland Frontiers Media S.A 23.04.2021
Subjects
Breast Cancer
ERBB3
HER3
HER3-DXd
Oncology
patritumab deruxtecan
U3-1402
ERBB3
HER3-DXd
CelTIL Score
Breast Cancer
U3-1402
HER3
patritumab deruxtecan
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Summary: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). 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. EudraCT 2019-004964-23; NCT number: NCT04610528.
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This article was submitted to Women's Cancer, a section of the journal Frontiers in Oncology
Edited by: Sara M. Tolaney, Dana–Farber Cancer Institute, United States
Reviewed by: Pedro Exman, Oncoclinicas Group, Brazil; Shigehira Saji, Fukushima Medical University, Japan
ISSN:2234-943X
2234-943X
DOI:10.3389/fonc.2021.638482