LOS ANGELES — The ENDORSE clinical trial is now open for enrollment at City of Hope. The Phase 1 study (NCT07590583) evaluates whether a tumor biopsy–based, biology-guided therapy report powered by Unravel's Endorse bx platform can help physicians determine effective standard-of-care treatment for patients with hormone receptor-positive, HER2-negative advanced, unresectable, or metastatic breast cancer.
ENDORSE (Evaluation of Novel Data-driven Outcomes via Response-guided Systems Medicine in Hormone Receptor-positive Advanced Breast Cancer) is sponsored by City of Hope Medical Center with support from the National Cancer Institute. After progression on first-line endocrine therapy, eligible participants have tumor tissue analyzed to produce a clinical report within approximately 30 days. The report includes Endorse signature and mTOR signature scores, along with biomarkers such as ESR1, PIK3CA, and HER2 mutations, with predicted sensitivity or resistance to endocrine therapy and targeted combinations.
The study's primary objective is to assess the feasibility and utility of this systems medicine approach for predicting estrogen dependence and guiding therapy selection. Secondary endpoints include accrual rate, clinical benefit rate, progression-free survival, duration of response, and therapy acceptance rate. The trial aims to enroll approximately 20 patients at City of Hope Medical Center in Duarte and City of Hope at Irvine Lennar in Irvine, California.
Eligible patients are adults with histologically confirmed HR+/HER2- unresectable or metastatic breast cancer who have progressed on first-line endocrine therapy for advanced disease, or within two years of completing adjuvant CDK4/6 inhibitor treatment. Participants must have at least one lesion amenable to percutaneous core biopsy and an ECOG performance status of 0–2.
Physicians receive treatment recommendations based on each patient's tumor biology and determine a regimen that may or may not follow the report. Blood samples and imaging are collected throughout the study, with optional tumor biopsy at progression. Exploratory objectives include genomic, epigenomic, and transcriptomic profiling of resistance mechanisms to inform future AI-guided therapy selection.
For more information about ENDORSE, visit clinicaltrials.gov/study/NCT07590583 or contact City of Hope clinical trials at 855-970-2654.