Natera Announces Enrollment of First Patients in the HEROES Clinical Trial in Metastatic HER2+ Breast Cancer
Natera (NASDAQ: NTRA) has initiated the HEROES clinical trial, enrolling its first patients to study the potential discontinuation of anti-HER2 targeted therapy in metastatic HER2+ breast cancer patients. The phase II trial, supported by the French Ministry of Health and sponsored by Unicancer, will involve approximately 170 patients across 35 French sites.
The study focuses on patients with HER2+ breast cancer, which affects 15-20% of breast tumors. Using Natera's Signatera™ testing, the trial will monitor patients who discontinue anti-HER2 maintenance therapy, with the primary endpoint being 1-year progression-free survival in Signatera-negative patients.
Key protocol elements include baseline testing of patients who have been on standard-of-care anti-HER2 therapy for two or more years. Signatera-negative patients will stop treatment and undergo regular monitoring, while Signatera-positive patients will continue maintenance therapy. Treatment will resume if radiological progression is confirmed or if a patient becomes Signatera-positive.
Natera (NASDAQ: NTRA) ha avviato il trial clinico HEROES, arruolando i suoi primi pazienti per studiare la possibile interruzione della terapia mirata anti-HER2 nei pazienti con cancro al seno metastatico HER2+. Il trial di fase II, sostenuto dal Ministero della Salute francese e sponsorizzato da Unicancer, coinvolgerà circa 170 pazienti in 35 centri francesi.
Lo studio si concentra sui pazienti con cancro al seno HER2+, che colpisce il 15-20% dei tumori mammari. Utilizzando il test Signatera™ di Natera, il trial monitorerà i pazienti che interrompono la terapia di mantenimento anti-HER2, con l'obiettivo primario di valutare la sopravvivenza libera da progressione a 1 anno nei pazienti negativi al Signatera.
Elementi chiave del protocollo includono il test iniziale dei pazienti che sono stati in terapia anti-HER2 standard per due o più anni. I pazienti negativi al Signatera interromperanno il trattamento e saranno sottoposti a monitoraggio regolare, mentre i pazienti positivi al Signatera continueranno la terapia di mantenimento. Il trattamento riprenderà se viene confermata una progressione radiologica o se un paziente diventa positivo al Signatera.
Natera (NASDAQ: NTRA) ha iniciado el ensayo clínico HEROES, inscribiendo a sus primeros pacientes para estudiar la posible interrupción de la terapia dirigida anti-HER2 en pacientes con cáncer de mama metastásico HER2+. El ensayo de fase II, respaldado por el Ministerio de Salud francés y patrocinado por Unicancer, involucrará aproximadamente a 170 pacientes en 35 sitios franceses.
El estudio se centra en pacientes con cáncer de mama HER2+, que afecta al 15-20% de los tumores mamarios. Utilizando la prueba Signatera™ de Natera, el ensayo monitoreará a los pacientes que interrumpen la terapia de mantenimiento anti-HER2, con el objetivo primario de evaluar la supervivencia libre de progresión a 1 año en pacientes negativos para Signatera.
Los elementos clave del protocolo incluyen pruebas iniciales de pacientes que han estado en terapia anti-HER2 estándar durante dos o más años. Los pacientes negativos para Signatera dejarán el tratamiento y serán monitoreados regularmente, mientras que los pacientes positivos para Signatera continuarán con la terapia de mantenimiento. El tratamiento se reanudará si se confirma una progresión radiológica o si un paciente se vuelve positivo para Signatera.
Natera (NASDAQ: NTRA)는 HEROES 임상 시험을 시작하여 전이성 HER2+ 유방암 환자에서 anti-HER2 표적 치료의 잠재적 중단을 연구하기 위해 첫 환자를 등록했습니다. 프랑스 보건부의 지원을 받고 Unicancer가 후원하는 이 2상 시험은 약 170명의 환자가 35개의 프랑스 사이트에서 참여할 예정입니다.
이 연구는 유방암 HER2+ 환자에 초점을 맞추고 있으며, 이는 유방 종양의 15-20%에 영향을 미칩니다. Natera의 Signatera™ 테스트를 사용하여, 이 시험은 anti-HER2 유지 치료를 중단하는 환자를 모니터링하며, 주요 목표는 Signatera 음성 환자의 1년 무진행 생존율입니다.
프로토콜의 주요 요소는 2년 이상 표준 치료를 받은 환자의 기초 테스트를 포함합니다. Signatera 음성 환자는 치료를 중단하고 정기적으로 모니터링을 받으며, Signatera 양성 환자는 유지 치료를 계속합니다. 방사선학적 진행이 확인되거나 환자가 Signatera 양성이 되면 치료가 재개됩니다.
Natera (NASDAQ: NTRA) a lancé l'essai clinique HEROES, inscrivant ses premiers patients pour étudier la possible interruption de la thérapie ciblée anti-HER2 chez les patients atteints de cancer du sein métastatique HER2+. Cet essai de phase II, soutenu par le ministère français de la Santé et sponsorisé par Unicancer, impliquera environ 170 patients sur 35 sites en France.
L'étude se concentre sur les patients atteints de cancer du sein HER2+, qui représentent 15 à 20 % des tumeurs mammaires. En utilisant le test Signatera™ de Natera, l'essai surveillera les patients qui interrompent la thérapie de maintien anti-HER2, l'objectif principal étant la survie sans progression à 1 an chez les patients négatifs pour Signatera.
Les éléments clés du protocole incluent des tests de base pour les patients ayant reçu une thérapie anti-HER2 standard pendant deux ans ou plus. Les patients négatifs pour Signatera arrêteront le traitement et seront soumis à un suivi régulier, tandis que les patients positifs pour Signatera continueront la thérapie de maintien. Le traitement sera repris si une progression radiologique est confirmée ou si un patient devient positif pour Signatera.
Natera (NASDAQ: NTRA) hat die HEROES-Studie gestartet und die ersten Patienten eingeschrieben, um die mögliche Beendigung der anti-HER2-gezielten Therapie bei metastasierten HER2+ Brustkrebspatienten zu untersuchen. Die Phase-II-Studie, die vom französischen Gesundheitsministerium unterstützt und von Unicancer gesponsert wird, wird etwa 170 Patienten an 35 französischen Standorten einbeziehen.
Die Studie konzentriert sich auf Patienten mit HER2+ Brustkrebs, der 15-20% der Brusttumore betrifft. Mit Nateras Signatera™-Test wird die Studie Patienten überwachen, die die anti-HER2-Erhaltungstherapie abbrechen, wobei der primäre Endpunkt das 1-Jahres-Überleben ohne Progression bei Signatera-negativen Patienten ist.
Wichtige Protokollelemente umfassen Basistests von Patienten, die seit zwei oder mehr Jahren in der Standardtherapie gegen HER2 sind. Signatera-negative Patienten werden die Behandlung abbrechen und regelmäßig überwacht, während Signatera-positive Patienten die Erhaltungstherapie fortsetzen. Die Behandlung wird wieder aufgenommen, wenn eine radiologische Progression bestätigt wird oder wenn ein Patient Signatera-positiv wird.
- First clinical trial using Signatera for therapy de-escalation in metastatic breast cancer, expanding product applications
- Government funding support from French Ministry of Health
- Large-scale trial with 170 patients across 35 sites
- Potential to reduce unnecessary treatment costs and side effects for patients
- Results and commercial impact won't be known until trial completion
- to HER2+ breast cancer subset (15-20% of breast tumors)
- Trial restricted to French sites only
Insights
Natera's announcement of first patient enrollment in the HEROES trial represents a significant strategic expansion of their Signatera test's clinical utility. This phase II trial aims to use ctDNA monitoring to guide treatment de-escalation decisions in metastatic HER2+ breast cancer - a novel approach addressing a clear unmet need.
The trial design is particularly noteworthy. By focusing on patients who have been stable on anti-HER2 therapy for two or more years, the study addresses a critical clinical question: can we safely discontinue lifelong maintenance therapy in select patients? Currently, these patients face indefinite treatment, with associated toxicities and financial burden.
The 170-patient study incorporates a pragmatic monitoring protocol where Signatera-negative patients discontinue therapy while undergoing regular testing. If they become Signatera-positive or show radiological progression, treatment resumes - creating a safety net for this de-escalation approach.
This represents Natera's strategic positioning of Signatera beyond monitoring into treatment decision-making. French government funding adds external validation to this approach. While first-patient enrollment marks early progress, the primary endpoint of 1-year progression-free survival will be the critical measure of success.
This trial initiation highlights Natera's strategic advancement of Signatera into the therapy optimization space, potentially transforming it from primarily a monitoring tool into one that guides critical treatment decisions. The HER2+ metastatic breast cancer market represents a significant opportunity, as 15-20% of breast tumors are HER2-positive.
The HEROES trial addresses a persistent clinical dilemma that has substantial economic implications. Current standard-of-care requires indefinite anti-HER2 maintenance therapy - these biologics typically cost
The multi-center approach across 35 sites in France demonstrates institutional confidence in the concept. Notably, the French Ministry of Health funding and Unicancer sponsorship provide external validation of the approach's potential clinical and economic value.
While commercial impact remains years away pending trial results, this represents Natera's strategic positioning at the intersection of precision diagnostics and treatment optimization. Success would establish Signatera as an essential component of the HER2+ treatment algorithm rather than an optional monitoring tool, potentially transforming utilization patterns and reimbursement opportunities.
HEROES is Natera’s first clinical trial using Signatera™ to guide de-escalation of therapy in patients with metastatic HER2+ breast cancer
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
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,
“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.
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
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 SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
References
- 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250309404104/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
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