Natera Announces Enrollment of First Patients in the HEROES Clinical Trial in Metastatic HER2+ Breast Cancer
HEROES is
Approximately 170 patients are expected to enroll in up to 35 sites in
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
“We are excited to see the first patients enrolled in the HEROES clinical trial,” said
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.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
About Unicancer
Unicancer is the only French hospital network 100% dedicated to the fight against cancer and the only national hospital federation dedicated to oncology. It brings together 18 Centres de lutte contre le cancer (CLCC), private non-profit healthcare establishments, spread over 20 hospital sites in
Unicancer is also the leading academic promoter of clinical trials in oncology at the European level, with 106 active clinical trials promoted in 2020 and nearly 7,600 patients included. Unicancer also runs flagship programmes that use real-life data to improve knowledge and the evaluation of therapeutic strategies, particularly through the ESME platforms, which bring together data from more than 76,000 cancer patients.
Recognised as a leader in research in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or our expectations of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the
References
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American Cancer Society . Breast Cancer HER2 Status. https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html
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