With funding provided by the French Ministry of Health, in addition to a sponsorship from Unicancer, Natera, Inc. has enrolled the first patients in its HEROES phase II clinical trial (NCT06450314), as reported by Business Wire.
The 170 patients enrolled all have metastatic HER2+ breast cancer and have been treating with SOC anti-HER2 targeted therapies for at least two years. The study will assess the effects of discontinuing or decreasing those therapies, using Signatera testing, by examining circulating tumor DNA, or ctDNA.
Signatera is a test for patients with cancer previously that is custom-built to the individual. The test is designed to measure any molecular cancer residuals in the body to calculate recurrence probability and determine remaining disease quantity, all in effort to better understand best treatment paths.
At the start of the trial, Signatera-negative patients will discontinue their anti-HER2 treatment therapies for one year, as long as no radiological progression develops, and they stay Signatera-negative. If progression is discovered during participation or their status changes to Singatera-positive, they will resort back to their previous therapies or be put on a new treatment plan.
Signatera-positive patients at baseline will continue maintenance therapies and will cease participation in the trial.
The HEROES trial’s primary endpoint is for patients to be progression-free after one year. The study will also evaluate the potential of using ctDNA-guided reduction or discontinuance methods for patients with no residual disease completely.
Source: Business Wire
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HEROES Clinical Trial Metastatic Her2+ Breast Cancer NCT06450314 Signatera
Last modified: March 10, 2025
