Natera, MEDSIR to Collaborate on MiRaDoR Breast Cancer Trial

Original from: genomeweb

Natera said Friday that it is collaborating with oncology research firm Medica Scientia Innovation Research (MEDSIR) on the MiRaDoR breast cancer trial for hormone receptor-positive, HER2-negative breast cancer. 

The multicenter Phase II clinical trial, which is sponsored by MEDSIR and funded by F. Hoffman-La Roche, will use Signatera Genome to evaluate the efficacy of different therapeutic approaches in early-stage HR+/HER2- breast cancer. 

Up to 60 patients who are Signatera-positive without clinical or radiological evidence of disease recurrence will be sequentially enrolled into one of four treatment arms, Natera said in a statement. Arm A will use standard-of-care endocrine therapy given during the first 90-day period and then patients will switch to another arm. Arm B will use giredestrant, an oral selective estrogen receptor degrader, while Arm C will use giredestrant plus abemaciclib, a CDK4/6 inhibitor. Arm D will use giredestrant plus inavolisib, a PIK3CA inhibitor for patients with PIK3CA mutations. 

The trial will allow investigators to evaluate serial circulating tumor DNA levels in each treatment arm as a predictive marker of treatment response, Natera said. The study's primary endpoint is the proportion of patients who have achieved a 90 percent decrease or clearance in baseline ctDNA after three months of treatment. 

Patients will receive additional Signatera testing at six, nine, and 12 months, and every six months thereafter until study treatment discontinuation. The results could help determine if specific therapy combinations are more effective in terms of ctDNA decrease than standard-of-care endocrine treatment, the company added. 

Enrollment in the trial is underway, with several UK sites already active and additional site activations expected in Europe in 2026. 

"Uniting Signatera Genome's ability to detect molecular residual disease with genomic profiling creates a new standard for precision oncology clinical trials," Angel Rodriguez, Natera's senior medical director of oncology, said in a statement. "In the MiRaDoR trial, investigators are moving beyond surveillance; they are also characterizing the specific genomic driver, PIK3CA, and no longer just asking 'Is the cancer back?' but also answering 'How do we treat it?'"

Source: Natera, MEDSIR to Collaborate on MiRaDoR Breast Cancer Trial