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Poster Display session 3

5574 - Results from TRIO030, a Pre-Surgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide


30 Sep 2019


Poster Display session 3


Translational Research

Tumour Site

Breast Cancer


Hsiao-Wang Chen


Annals of Oncology (2019) 30 (suppl_5): v25-v54. 10.1093/annonc/mdz239


H. Chen1, E. Von Euw1, P. Millan2, R. Fresco2, S. Carrez3, K. Afenjar3, H. Fung4, M. Burton5, A. Santiago6, R. Guzman6, I. Villalobos6, M. Press6, W. Eiermann7, D.J. Slamon1

Author affiliations

  • 1 Department Of Medicine, University of California Los Angeles, 90404 - Santa Monica/US
  • 2 Medical Unit, Translational Research in Oncology (TRIO), 11700 - Montevideo/UY
  • 3 Project Management, Translational Research in Oncology (TRIO), Paris/FR
  • 4 Biostatistics, Translational Research in Oncology (TRIO), Edmonton/CA
  • 5 Data Management, Translational Research in Oncology (TRIO), Edmonton/CA
  • 6 Department Of Pathology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles/US
  • 7 Obstetrics And Gynecology, Interdisziplinäre Onkologische Zentrum München, Munich/DE


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Abstract 5574


The role of the androgen receptor (AR) in breast cancer (BC) is not fully elucidated. TRIO030 was conducted to identify molecular changes in BC tissue following short-term exposure to darolutamide (DAR), a new next-generation AR antagonist.


TRIO030 was a multicenter, tissue-acquisition trial in women with treatment-naïve early BC, T ≥ 1.0 cm, N0-1. Primary objective: identify molecular alterations in BC tissue following preoperative exposure to DAR (600mg bid for 14-35 days). Formalin-fixed paraffin-embedded (FFPE) blocks and fresh frozen tissue (FFT) were collected before DAR and at surgery (or pre neoadjuvant therapy). AR, ER, PgR, HER2, Ki67, Cytokeratin 5-6 were assessed by IHC. Gene expression microarray (GEx) and Reverse Phase Protein Analysis (RPPA) were done on FFT. Differentially expressed genes (DEGs) were found by ANOVA from an integrated gene expression analysis software (Resolver). A gene enrichment search by Gene Ontology (GO) analysis was done using Database for Annotation, Visualization and Integrated Discovery (DAVID).


36 patients (pt) (median age 61.5) were enrolled (20 HR+, 7 TNBC, and 9 HER2+ per central lab). Median duration of DAR was 14.5 days. 32 pts were evaluable by RPPA, 31 by GEx. Based on AR level changes in both RPPA and GEx in pre vs. post-DAR samples, cases were grouped: AR upregulated (≥1.2 fold increase, n = 14), AR downregulated (≥1.2 fold decrease, n = 11), AR unchanged (n = 6). 233 unique DEGs were detected with 84 identified as forming two GEx profiles among the 3 AR groups. GO analysis revealed that DEGs profiles were enriched in an immune (IMM) signature or cell proliferation (CP) signature which were anti-correlated (e.g., if CP is upregulated, IMM is down). No correlation between AR groups and BC subtypes was found. One pt had a grade 3-4 adverse event (non-serious ALT-AST increase).


TRIO030 suggests an association between DAR and immune regulation genes. There was no association between pre/post-DAR AR level changes and BC subtype. Future studies will likely be needed to further investigate the role for AR blockade in BC as well as the mechanism of action for DAR at molecular level.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Translational Research in Oncology.


Bayer (provided the study drug), Translational Research in Oncology (not for profit organization, funded other aspects of the trial).


All authors have declared no conflicts of interest.

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