New Combination Therapy Offers Hope for Advanced Breast Cancer Patients
Berlin,Germany – A novel treatment combining giredestrant and everolimus has demonstrated robust activity and a manageable safety profile in patients with estrogen receptor-positive (ER+),HER2-negative advanced breast cancer whose disease has progressed after prior CDK4/6 inhibitor therapy,according to primary results from the Phase III evERA BC trial presented at the European Society For Medical Oncology (ESMO) 2025 Congress. The findings suggest a promising new option for a challenging-to-treat population, especially those harboring ESR1 mutations.
This breakthrough addresses a critical need for patients who have tired standard treatments. Approximately 70% of advanced breast cancers are ER+, but resistance to initial endocrine therapies, including CDK4/6 inhibitors, frequently develops. the evERA BC trial,evaluating giredestrant plus everolimus against physician’s choice of endocrine therapy plus everolimus,offers a potential solution for extending survival and improving quality of life for these individuals. Investigators concluded the regimen could represent a significant advancement in the treatment landscape, offering renewed hope where options are limited.
The study revealed that Grade 3 or 4 adverse events were infrequent, and treatment discontinuations due to adverse events were relatively low, with 8.2% in the giredestrant arm compared to 6.5% in the standard endocrine therapy arm. A small proportion of patients (3.8%) receiving giredestrant experienced grade 1 bradycardia,but this did not necessitate treatment interruption or discontinuation.
The evERA BC trial is registered on Clinicaltrials.gov as NCT05306340 and was updated as recently as november 12, 2025. Further details about the trial can be found at https://clinicaltrials.gov/study/NCT05306340. The research was led by E. Mayer, S. Tolaney, M. Martin, and colleagues, and presented at the ESMO 2025 Congress, October 17-21, 2025, in Berlin, Germany.