Palbociclib in Early Stage Breast Cancer based on ctDNA Monitoring
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Phase 2 Trial to Study Palbociclib in Early Stage Breast Cancer Based on ctDNA Monitoring
October 10, 2020
Natera’s Signatera ctDNA test will determine study eligibility and treatment effectiveness in HR-positive, HER2-negative breast cancer patients.
Natera’s molecular residual disease (MRD) test, Signatera, will be used in an upcoming phase 2 trial of palbociclib (Ibrance), a CDK4/6 inhibitor developed by Pfizer, in combination with fulvestrant for the treatment of early stage HR-positive, HER2-negative breast cancer.
The prospective DARE trial, which will be run by Criterium, Inc. known as the Academic Breast Cancer Consortium (ABRCC) network, will include about 100 stage II-III, HR-positive, HER2-negative breast cancer patients currently undergoing adjuvant endocrine therapy. MRD-positive patients identified with Signatera test results will be randomized to either continue with their current endocrine therapy or begin a regimen of palbociclib in combination with an aromatase inhibitor or fulvestrant for 2 years.
Palbociclib was the first CDK4/6 inhibitor approved by the FDA for use in conjunction with endocrine therapy in advanced HR-positive, HER2-negative advanced breast cancer, but research has yet to determine its efficacy in early-stage disease. Throughout the trial, continued molecular monitoring with Signatera ctDNA testing will be used to track treatment effectiveness.
“These are women who have molecular recurrence, but not clinical radiological recurrence,” Natera senior medical director Alexey Aleshin, MD, MBA, told The American Journal of Managed Care® (AJMC®) in an interview. “Can we actually treat these women with the now preferred frontline metastatic regimen, which is palbociclib, to see if some of these women can have their outcomes improved with this early intervention strategy compared to the standard of care, which, unfortunately, is actually just continuing the endocrine therapy that these women are on?”
“If we can show in the study that by treating women earlier using knowledge that they have molecular recurrence, not only can we delay recurrence in some of these women, but possibly cure some of them and actually prevent somebody from developing metastatic disease that invariably is lethal in many of these women, that'll be a huge advancement for the field and clearly demonstrate why doing a test like Signatera is beneficial in the setting,” Aleshin said.