Year: 2025
Type: article
Abstract: Circulating tumor DNA (ctDNA) is a promising biomarker in early hormone receptor (HR) + , HER2-negative breast cancer. We assessed ctDNA with the RaDaR assay in NeoRHEA (NCT03065621), a single-arm, phase II neoadjuvant palbociclib plus endocrine therapy trial over 4 months (4 × 28-day cycles). Plasma samples were drawn pre-treatment, after cycle 1, pre-surgery, and 1 month post-surgery. Baseline ctDNA was detected in 55%, fell to 5% during treatment, and was undetectable in all patients by 1-month post-surgery. Baseline detection was higher in grade 3 tumors, lower in multifocal/multicentric disease, and higher in residual cancer burden (RCB) 3. MYC gains/amplifications were enriched in ultrasound (US) responders, while PIK3CA gains were enriched in US non-responders; FAT1 losses were enriched in RCB 3. Baseline ctDNA predicted poor response to this regimen, supporting ctDNA as a biomarker to guide treatment in HR + /HER2-negative disease. Trial registration: EU Clinical Trials Register (EudraCT 2016-000879-24; registered 15 February 2017).
Source: npj Breast Cancer
Authors: Alexandra Stanciu, Elisa Agostinetto, Andreas Papagiannis, Christodoulos Pipinikas, Amber Chevalier, Nathan Campbell, Mariana Brandão, Lieveke Ameye, Marianne Paesmans, Tatiana Besse, Francoise Rothe, Laurence Buisseret, Donatienne Taylor, Patrick Neven, Christos Sotiriou, Francois P. Duhoux, Peter Vuylsteke, Michail Ignatiadis
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,790
Funder: Pfizer
OpenAlex ID: W4417033852