Prospective real-world evidence reinforces EndoPredict’s strong prognostic performance
Three-year interim results from the prospective, international RESCUE study were presented at the ESMO Congress 2026 in Madrid. The findings demonstrate that EndoPredict (EPclin) risk groups were associated with significantly different outcomes in patients with hormone receptor-positive (HR+), HER2-negative early breast cancer.
The RESCUE study (Reaching for Evidence-based Chemotherapy Use in Endocrine Sensitive Breast Cancer), conducted in cooperation with NOGGO (North-Eastern German Society of Gynecological Oncology) and led by Prof. Dr. Marion Kiechle as Principal Investigator, evaluates EndoPredict risk assessment in routine clinical practice. Presented by PD Dr. Evelyn Klein (Munich, Germany), this interim analysis represents the largest prospective trial of EndoPredict to date.
Study at a glance
- Study design: Prospective, international, multicenter healthcare study
- Study population: 1,107 patients with HR+/HER2− primary invasive breast cancer, stage I/II, with 0–3 positive lymph nodes
- Participating centers: 44 breast centers in Germany and Switzerland
- Analysis: Pre-planned interim analysis
- Enrollment period: July 2018 to September 2022
- Median follow-up: 49.4 months
Key findings from the three-year interim analysis
Differentiation of disease-free survival
Three-year breast cancer-related disease-free survival (DFS) was 98.5% in patients classified as EPclin low risk and 96.9% in those classified as high risk (p = 0.04).
Favorable distant metastasis-free survival in the low-risk group
No breast cancer-related distant metastasis events were observed in the EPclin low-risk group during the reported analysis period, compared with 22 events in the high-risk group.
Three-year breast cancer-related distant metastasis-free survival (DMFS) was:
- EPclin low risk: 100.0%
- EPclin high risk: 98.2%
The difference was statistically significant (p = 0.0002).
Consistent risk differentiation across menopausal status
EndoPredict differentiated distant metastasis risk in both premenopausal and postmenopausal patients.
| Patient subgroup | EPclin low risk: 3-year DMFS | EPclin high risk: 3-year DMFS | p-value |
| Premenopáusica | 100.0% | 97.3% | 0.005 |
| Postmenopausal | 100.0% | 98.6% | 0.01 |
Additional risk stratification across Ki-67 levels
EndoPredict further differentiated three-year breast cancer-related distant metastasis-free survival (bcr DMFS) in patients with both low and high Ki-67 levels.
| Ki-67 subgroup | EPclin low risk: 3-year DMFS | EPclin high risk: 3-year DMFS | p-value |
| Low Ki-67 (≤10%) | 100.0% | 98.8% | 0.02 |
| High Ki-67 (≥20%) | 100.0% | 97.9% | 0.03 |
These findings highlight EndoPredict’s ability to further differentiate distant metastasis risk across different levels of tumour proliferation, providing additional prognostic information beyond Ki-67 alone.
What do these findings mean?
Across the evaluated survival endpoints, patients classified as EPclin high risk consistently showed less favorable outcomes than those classified as low risk. Importantly, risk differentiation was also observed in both premenopausal and postmenopausal patients, as well as in patients with both low and high Ki-67 levels. These findings highlight EndoPredict’s ability to refine prognostic risk assessment beyond conventional clinical and proliferation markers.
These interim results add important prospective evidence from routine clinical practice to the clinical evaluation of EndoPredict in early HR+/HER2− breast cancer, further supporting its role in individualized risk stratification.
Looking ahead
The RESCUE study is ongoing. Five- and ten-year outcome data are planned for future analysis and will provide further information on longer-term patient outcomes.
Referencia:
Klein E. et al. Three-year interim real-world data analysis from the prospective, international, multicenter RESCUE trial. ESMO Congress 2026, Poster 1901eP.
Principales conclusiones
- Three-year interim data from the RESCUE study shows EndoPredict (EPclin) risk groups correlate with different outcomes in HR+/HER2− early breast cancer patients.
- The study involved 1,107 patients from 44 centers and demonstrated that EPclin low-risk patients had a 98.5% disease-free survival rate.
- EndoPredict showed consistent risk differentiation in premenopausal and postmenopausal patients, highlighting its effectiveness across groups.
- Additionally, it differentiated risk across Ki-67 levels, offering more nuanced prognostic information.
- The ongoing RESCUE study aims to provide five- and ten-year outcome data for a comprehensive understanding of patient outcomes.
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