NEW YORK – Natera said on Thursday that it is collaborating with Mass General Cancer Center of Massachusetts General Hospital on an early-stage breast cancer clinical trial of a molecularly targeted therapy.
The investigator-initiated, multi-center, Phase II randomized trial, called LEADER, will evaluate Ribociclib (Novartis' Kisqali), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer.
It will study patients with localized post-menopausal breast cancer who have detectable circulating tumor DNA after surgery, indicating minimal residual disease, and will determine tumor molecular response after Ribociclib in combination with endocrine therapy versus endocrine therapy alone.
The trial will use Natera's Signatera personalized liquid biopsy test to determine patient enrollment eligibility based on the presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint.
"With the overwhelming evidence that patients with detectable ctDNA are at high risk for relapse, our goal is to investigate a new treatment strategy for these patients and reduce risk of disease recurrence," said Aditya Bardia, the study's principal investigator at MGCC, in a statement. "Since the LEADER trial is in the MRD setting, it is critical to use a highly sensitive assay."
"We believe this collaboration may pave the way for more trials using ctDNA to study the effectiveness of an investigational drug in early-stage breast cancer," said Alexey Aleshin, senior medical director for oncology at Natera, in a statement.
Earlier this week, Natera said that the Signatera test had received the CE mark. The test, which is performed in a CLIA-certified lab, received Breakthrough Device Designation by the US Food and Drug Administration last year but has not yet been cleared for marketing by the agency.