Circulating tumor (ct)DNA monitoring of ER+/HER2- high-risk breast cancer during adjuvant endocrine therapy.

作者：Lajos Pusztai, Carly Bess Scalise, Ekaterina Kalashnikova, Ursa Brown Glaberman, Sima Ehsani, Alison Stopeck, Manali Bhave, Alexandra Dos Santos Zimmer, Evanthia T. Roussos Torres, Paula Klein, Sagar Sardesai, Fengting Yan, Marina N. Sharifi, Peter Kabos, Wajeeha Razaq, Michelle Marie Loch, Angel Rodriguez, Minetta C. Liu · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.1010 · 被引用次数：12 · 研究领域：Cancer Genomics and Diagnostics、Breast Cancer Treatment Studies、Advanced Breast Cancer Therapies

1010 Background: ctDNA monitoring during adjuvant endocrine therapy is an opportunity to detect molecular relapse before clinically apparent recurrence. ctDNA positivity rates, dynamics and the frequency of asymptomatic imaging-detectable metastatic disease at the time of ctDNA detection remain unknown in high-risk ER+/HER2- BCs. We present ctDNA results from a prospective, multicenter, randomized ctDNA interventional trial, DARE (NCT04567420). Methods: Patients receiving adjuvant endocrine therapy for >6 months but <7 years, with either recurrence risk >15% (PREDICT, RSPC, CTS5), >4 positive axillary lymph nodes, (primary tumor >5 cm, or 1-3 positive nodes with grade 3 histology, or >3 cm tumor, or high molecular risk (Oncotype Dx RS >26, MammaPrint high risk, EndoPredict >4, Prosigna score >60) were eligible for ctDNA surveillance with the Signatera assay (Natera, Inc.) every 6 months. ctDNA+ patients had systemic staging with imaging and if there was no evidence of metastatic disease patients were randomized to switching to fulvestrant + palbociclib (Arm A) or to continuation of adjuvant therapy (Arm B). Negative predictive value (NPV) was calculated for recurrence in the screening group after each ctDNA- test. In randomized patients, early ctDNA dynamics were correlated with recurrence-free survival (RFS) and ctDNA clearance rates were calculated by trial arm. Results: 552 patients had tissue sent for assay design; 494 had ctDNA results; 52 failed WES and/or had incomplet...