Benzinga | Oct 2, 2020 09:04AM EDT

Natera Announces Prospective Randomized Clinical Trial To Evaluate Palbociclib In Early Stage Breast Cancer Patients Who Test Positive With Signatera

SAN CARLOS, Calif., Oct. 2, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cell-free DNA, today announced that its Signatera molecular residual disease (MRD) test will be used in the DARE study, a multi-center clinical trial of palbociclib (IBRANCE(r)), 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.

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."