Breast Cancer Evaluation and Targeted Investigational Therapy (BEAT-IT): A Pilot Prospective Tissue-Testing Study for Breast Cancer Clinical Trial Enrollment
Abstract
Background Metastatic breast cancer (mBC) is heterogeneous not only clinically but genomically. Beyond 2–3 lines of therapy, many patients lack access to rationally selected investigational therapies. We evaluated whether a prospective, multi-omics assay from obtained tissue could 1) identify actionable alterations with rapid turnaround and 2) channel patients to biomarker-matched clinical trials, while maintaining procedural safety. Methods BEAT-IT was a prospective study in which core biopsies from patients with mBC (primary and metastatic lesions) were evaluated using immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and next-generation sequencing (NGS). Primary endpoint was the proportion of patients bearing actionable alterations and the proportion referred to biomarker-matched trials. Secondary endpoints included turnaround time (TAT) and biopsy-related morbidity. Proportions are reported with Wilson 95% confidence intervals (CIs). Exploratory subgroup comparisons including molecular subtype comparison were planned with chi-square or Fisher's exact tests. Results Among the 157 enrolled participants, the median TAT from biopsy to finalized report was 20 days. Actionable alterations were identified in 49.0% (77/157; 95% CI 41.3–56.8%). Overall, 49 of 157 patients (31.2%; 95% CI 24.5–38.8%) enrolled in at least one therapeutic clinical trial after profiling. A single grade 1 pneumothorax (1/162 biopsied patients, 0.6%) was the only biopsy-related complication. Retrospective annotation using current ESCAT criteria identified a tier I alteration in 20% of patients with tumor-informative DNA results. Conclusions Prospective, biopsy-triggered multi-omics profiling in mBC is feasible, safe, and delivers clinically actionable results within approximately 3 weeks. Our approach identified actionable alterations in approximately half of patients and supported enrollment in therapeutic clinical trials for nearly one-third. Trial registration: This study evaluated a diagnostic/implementation strategy without assignment to a therapeutic intervention; clinical-trial registration was not required.
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BibTeX
@misc{chamorro2026breast,
title = {{Breast Cancer Evaluation and Targeted Investigational Therapy (BEAT-IT): A Pilot Prospective Tissue-Testing Study for Breast Cancer Clinical Trial Enrollment}},
author = {Diego F. Chamorro and Evthokia Hobbs and Meghan Karuturi and Elyse Lopez and Lumarie Santiago and Rony Avritscher and Aysegul Sahin and Funda Meric-Bernstam and Bora Lim},
howpublished = {Research Square},
year = {2026},
month = oct,
doi = {10.21203/rs.3.rs-10936036/v1},
url = {https://europepmc.org/article/PMC/PMC13742820},
note = {CC BY},
}
RIS
TY - UNPB
TI - Breast Cancer Evaluation and Targeted Investigational Therapy (BEAT-IT): A Pilot Prospective Tissue-Testing Study for Breast Cancer Clinical Trial Enrollment
AU - Diego F. Chamorro
AU - Evthokia Hobbs
AU - Meghan Karuturi
AU - Elyse Lopez
AU - Lumarie Santiago
AU - Rony Avritscher
AU - Aysegul Sahin
AU - Funda Meric-Bernstam
AU - Bora Lim
PY - 2026
DA - 2026/10/14
PB - Research Square
DO - 10.21203/rs.3.rs-10936036/v1
UR - https://europepmc.org/article/PMC/PMC13742820
AB - Background Metastatic breast cancer (mBC) is heterogeneous not only clinically but genomically. Beyond 2–3 lines of therapy, many patients lack access to rationally selected investigational therapies. We evaluated whether a prospective, multi-omics assay from obtained tissue could 1) identify actionable alterations with rapid turnaround and 2) channel patients to biomarker-matched clinical trials, while maintaining procedural safety. Methods BEAT-IT was a prospective study in which core biopsies from patients with mBC (primary and metastatic lesions) were evaluated using immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and next-generation sequencing (NGS). Primary endpoint was the proportion of patients bearing actionable alterations and the proportion referred to biomarker-matched trials. Secondary endpoints included turnaround time (TAT) and biopsy-related morbidity. Proportions are reported with Wilson 95% confidence intervals (CIs). Exploratory subgroup comparisons including molecular subtype comparison were planned with chi-square or Fisher's exact tests. Results Among the 157 enrolled participants, the median TAT from biopsy to finalized report was 20 days. Actionable alterations were identified in 49.0% (77/157; 95% CI 41.3–56.8%). Overall, 49 of 157 patients (31.2%; 95% CI 24.5–38.8%) enrolled in at least one therapeutic clinical trial after profiling. A single grade 1 pneumothorax (1/162 biopsied patients, 0.6%) was the only biopsy-related complication. Retrospective annotation using current ESCAT criteria identified a tier I alteration in 20% of patients with tumor-informative DNA results. Conclusions Prospective, biopsy-triggered multi-omics profiling in mBC is feasible, safe, and delivers clinically actionable results within approximately 3 weeks. Our approach identified actionable alterations in approximately half of patients and supported enrollment in therapeutic clinical trials for nearly one-third. Trial registration: This study evaluated a diagnostic/implementation strategy without assignment to a therapeutic intervention; clinical-trial registration was not required.
SN - 2693-5015
ER -