Aditya Bardia, MD, MPH of Massachusetts General Hospital discusses the Natera Announces Collaboration with Massachusetts General Hospital for a Prospective Randomized Clinical Trial in Early Stage Breast Cancer.
SAN CARLOS, Calif., Aug. 27, 2020/PRNewswire/ — Natera, Inc. ( NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced a joint agreement with the Mass General Cancer Center (MGCC) of Massachusetts General Hospital, connected to the Phase II randomized clinical trial of Ribociclib (Kisqali ®), a CDK4/6 inhibitor, for the treatment of ER-pository multi-center treatment.
LEADER (Part II) will randomize patients with localized postmenopausal breast cancer as proof of limited residual disease (MRD) with observable ctDNA after surgery and will assess tumor molecular response after Ribociclib in conjunction with endocrine versus endocrine therapy alone. Natera’s Signatera test will be used to determine eligibility for patient participation based on longitudinal screening for the existence of ctDNA and to assess response based on ctDNA clearance as the primary endpoint.
In the US,1, and the U.S., breast cancer remains the second leading cause of cancer death in women. As a first-line treatment choice for advanced/metastatic (stage IV) illness, the Food and Drug Administration (FDA ) has approved Ribociclib in combination with aromatase inhibitors.