Natera (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, today announced their collaboration on the MiRaDoR (NCT05708235) study.
This multicenter, Phase II clinical trial will evaluate the efficacy of various therapeutic approaches in hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, a disease that represents approximately 70% of all breast cancer cases worldwide.
Breast cancer remains the most common cancer in women globally, with around 2.3 million new cases diagnosed in 2022.
Despite advancements in treatment, recurrence continues to be a significant concern for HR+/HER2- patients.
The MiRaDoR study, funded by F. Hoffman-La Roche Ltd. and sponsored by MEDSIR, will use Natera’s Signatera Genome to assess the effectiveness of different therapeutic strategies in early-stage HR+/HER2- breast cancer.
The trial will enroll up to 60 patients who are Signatera-positive but show no clinical or radiological evidence of disease recurrence.
The study’s primary endpoint will focus on the proportion of patients who achieve a 90% decrease or clearance in baseline circulating-tumor DNA (ctDNA) after three months of treatment.
Investigators will evaluate serial ctDNA levels at multiple time points to assess treatment response, with additional Signatera testing scheduled at 6, 9, and 12 months, and then every six months thereafter until study treatment discontinuation.
The results from the MiRaDoR study will help determine whether specific combinations of therapies are more effective in reducing ctDNA compared to standard endocrine treatments, marking a significant step forward in precision oncology for HR+/HER2- breast cancer.