On March 10, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported the enrollment of the first patients in the HEROES clinical trial. HEROES is a multi-center, phase II trial that explores the discontinuation or de-escalation of anti-HER2 targeted therapy among patients with metastatic HER2+ breast cancer (Press release, Natera, MAR 10, 2025, View Source [SID1234651050]). The trial is supported by funding from the French Ministry of Health through the Hospital Clinical Research Program (PHRC) and is being sponsored by Unicancer. It is being developed within Unicancer’s French Breast Cancer Intergroup (UCBG) network.

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Human epidermal growth factor receptor 2 (HER2) is a type of protein found in cancer cells that can cause rapid cancer growth when higher than normal levels are present. Between 15%-20% of breast tumors are HER2+.¹ Current standard-of-care (SOC) recommendations for maintenance treatment include the use of anti-HER2 therapies, which for many patients means remaining on the drug for life.

The HEROES (NCT06450314) trial will enroll approximately 170 metastatic HER2+ breast cancer patients who have discontinued anti-HER2 maintenance therapy. The primary endpoint of the study is 1-year progression-free survival in the Signatera-negative cohort. It will also assess ctDNA dynamics and quality-of-life measures to gain deeper insights into the potential for ctDNA-guided de-escalation of treatment in patients with no detectable molecular disease burden.

Highlights from the study protocol include:

At baseline, all patients are currently being treated with SOC anti-HER2 targeted therapies and have been on therapy for two or more years.
Signatera-negative patients at baseline will stop treatment and will be monitored with serial Signatera testing and diagnostic imaging. If at any point during the trial radiological progression is confirmed or a patient becomes Signatera-positive, prior drug therapy will resume or a new treatment will begin.
Signatera-positive patients at baseline will continue maintenance therapy and will not move forward in the trial.
"The HEROES study could significantly reshape the way oncologists treat patients with metastatic HER2+ breast cancer," said Thibault de la Motte Rouge, M.D., Ph.D., principal investigator of the trial and medical oncologist at the Comprehensive Cancer Centre Eugène Marquis (Rennes, France), where he currently holds the position of research director. "This could also pave the way for future research into ctDNA-guided treatment de-escalation in breast cancer."

"We are excited to see the first patients enrolled in the HEROES clinical trial," said Angel Rodriguez, M.D., senior medical director of oncology at Natera. "Safely discontinuing treatment has been a long-lasting dilemma in HER2 metastatic breast cancer. With Signatera monitoring, we hope oncologists can identify the patients without detectable disease who may be able to avoid additional therapy that can be costly and potentially harmful to their care."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.