On October 2, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, reported that its Signatera molecular residual disease (MRD) test will be used in the DARE study, a multi-center clinical trial of palbociclib (IBRANCE), a CDK4/6 inhibitor developed by Pfizer for the treatment of HR-positive, HER2-negative advanced breast cancer when given in combination with an aromatase inhibitor or fulvestrant (Press release, Natera, OCT 2, 2020, View Source [SID1234567995]).

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The DARE study is a randomized, Phase II trial of ctDNA-guided second line adjuvant therapy for stage II-III, HR-positive, HER2-negative breast cancer. DARE will be conducted in the United States through Criterium, Inc. d/b/a the Academic Breast Cancer Consortium (ABRCC) network, which plans to identify about 100 MRD-positive patients for enrollment in the study. These 100 patients will be randomized to continue their current adjuvant endocrine therapy or start treatment with palbociclib plus fulvestrant for two years. Signatera is to be used for patient enrollment eligibility and continued therapy effectiveness monitoring after randomization.

"Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity," said Lajos Pusztai, MD, DPhil, Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine and Principal Investigator of the trial. "Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging. The trial will test if early intervention at this stage could delay or avert a clinical relapse."

Palbociclib was the first CDK4/6 inhibitor to be approved by the FDA as a therapy for patients with HR-positive, HER2-negative advanced breast cancer when taken in combination with endocrine therapy; however, efficacy has not yet been demonstrated in early stage disease. Each year, approximately 69,000 women are diagnosed with Stage II or III HR-positive breast cancer in the United States.1,2

"We are delighted to collaborate with Yale and Criterium/ABRCC to investigate the efficacy of palbociclib in patients with detectable residual disease based on Signatera," said Alexey Aleshin, MD, MBA, Natera’s Senior Medical Director for Oncology. "This is the second clinical trial using Signatera to evaluate the efficacy of a CDK4/6 inhibitor, and it heralds the significant utility of personalized MRD testing for early relapse detection in patients with breast cancer."

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019 and The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.