NEW YORK – Natera said on Friday that its Signatera molecular residual disease test will be used in the DARE study, a multi-center clinical trial of palbociclib (Pfizer's Ibrance).
Palbociclib is a CDK4/6 inhibitor for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer in combination with an aromatase inhibitor or fulvestrant.
The DARE study is a randomized, Phase II trial of circulating tumor DNA-guided second-line adjuvant therapy for stage II and III hormone receptor-positive, HER-2 negative breast cancer with high residual risk. It will be conducted in the US by Criterium, known as the Academic Breast Cancer Consortium (ABRCC) network, and plans to enroll approximately 100 MRD-positive patients.
Patients will be randomized to either continue their current adjuvant endocrine therapy or start treatment with palbociclib and fulvestrant for two years.
The Signatera test will be used to determine patient eligibility for enrollment and to monitor therapy effectiveness during the trial.
"Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity," said Lajos Pusztai, professor of medicine at Yale School of Medicine and the principal investigator of the trial, in a statement. "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."
This is the second clinical trial in which Signatera will be used to study the efficacy of a CDK4/6 inhibitor. Last month, Natera said it is collaborating with Mass General Hospital on a Phase II trial called LEADER to evaluate Ribociclib (Novartis' Kisqali) to treat early-stage ER-positive breast cancer.