Angel A. Rodriguez, MD, Oncology Medical Director of Natera speaks about 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.
In patients previously diagnosed with cancer, Signatera is a custom-built ctDNA test for treatment tracking and MRD evaluation. The test is available for use in clinical and research and was given the FDA Breakthrough Product Designation in 2019. The Signatera test is personalized and tumor-informed, offering a standardized blood test designed for each individual to match the particular signature of clonal mutations contained in the tumor of that individual. This maximizes the precision of a blood sample's identification of the presence or absence of residual disease, even at levels down to a single tumor molecule in a blood tube. Signatera is not supposed to fit patients with any specific therapy, unlike a regular liquid biopsy. Instead, identifying and quantifying how much cancer is left in the body, identifying recurrence sooner, and helping to optimize care decisions are expected. In various cancer types, including colorectal, non-small cell lung, breast, and bladder cancers, Signatera's test success has been clinically validated. Signatera and its performance characteristics have been developed and determined by Natera, the CLIA-certified laboratory carrying out the test. The US Food and Drug Administration (FDA) has not cleared or approved the examination. Accredited by CAP, accredited by ISO 13485, and CLIA approved.