Inavolisib

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, today announced their collaboration on the MiRaDoR (NCT05708235) study, which is a multicenter, phase II clinical trial in hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer. Breast cancer is the most common cancer in women worldwide, with approximately 2.3 million new cases diagnosed in 2022.1 Despite advances in treatment, recurrence remains a key concern for patients with HR+/HER2- disease, which represents roughly 70% of all breast cancer cases.2 Funded by F. Hoffman-La Roche Ltd., and sponsored by MEDSIR, MiRaDoR will use Signatera Genome to evaluate the efficacy of different therapeutic approaches in early-stage HR+/HER2- breast cancer. Up to 60 patients who are Signatera-positive without clinical nor radiological evidence of disease recurrence will be sequentially enrolled into one of four treatment arms: Arm A: Standard of care endocrine therapy given during the first 90-day period, then patients switch to Arms B, C or D Arm B: Giredestrant (oral selective estrogen receptor degrader) Arm C: Giredestrant plus Abemaciclib (CDK4/6 inhibitor) Arm D: Giredestrant plus Inavolisib (PIK3CA inhibitor; for patients with PIK3CA mutations) The trial will enable investigators to evaluate serial circulating-tumor DNA (ctDNA) levels in each treatment arm as a predictive marker of treatment response. The study’s primary endpoint is the proportion of patients who have achieved a 90% decrease or clearance in baseline ctDNA after three months of treatment. Participants will have additional Signatera testing at 6, 9 and 12 months, and every six months thereafter until study treatment discontinuation. Results may help determine if specific therapy combinations are more effective in terms of ctDNA decrease than standard of care endocrine treatment. “Uniting Signatera Genome’s ability to detect molecular residual disease with genomic profiling creates a new standard for precision oncology clinical trials,” said Angel Rodriguez, M.D., senior medical director of oncology at Natera. “In the MiRaDoR trial, investigators are moving beyond surveillance; they are also characterizing the specific genomic driver, PIK3CA, and no longer just asking ‘is the cancer back?’ but also answering 'how do we treat it?’” Enrollment for MiRaDoR is underway, with several U.K. sites already active and additional site activations expected in Europe in 2026. References World Health Organization. Breast Cancer Fact Sheet. Last updated August 14, 2025. Available at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer American Cancer Society. Breast Cancer Facts & Figures 2024-2025 . Atlanta: American Cancer Society, Inc. 2024. About Natera Natera™ is a global leader in cell-free DNA and precision medicine, 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 supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com. About MEDSIR Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America. For further information: www.medsir.org Forward-Looking Statements (Natera) 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 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.

编者按：2025年12月10日上午，第48届圣安东尼奥乳腺癌研讨会（SABCS 2025）在美国圣安东尼奥正式开幕。作为全球乳腺癌领域规模最大、最具影响力的学术会议之一，本届SABCS汇聚了来自世界各地的科研人员、临床专家与倡导者。会议不仅展示了超过2200篇最新研究摘要，颁发多项重要学术奖项，更聚焦于健康公平、科研可持续资助等关键议题。在此，我们梳理开幕式重点内容，以期为读者呈现乳腺癌研究与临床实践的最新动态与未来走向。 亮点纷呈，聚焦关键领域 会议联合主席之一、德克萨斯大学健康科学中心的Virginia Kaklamani教授首先发表热情洋溢的欢迎辞。她指出，每年SABCS会议都会带来乳腺癌研究领域的诸多亮点，今年也不例外。众多转化研究项目、临床试验，尤其是具有开创性的临床试验将在会上呈现。其中，两周前才确定入选的lidERA研究备受关注，作为首个纳入本次会议口头报告的口服选择性雌激素受体降解剂（SERD）辅助治疗的试验，其结果于10日上午在大会“General Session 1”环节公布。 随后，Virginia Kaklamani教授介绍到，今年会议将聚焦两大重要研究领域：一是年轻女性乳腺癌患者诊疗，将深入探讨其生物学特征、治疗方案以及背后的伦理问题；二是人工智能（AI）在乳腺癌治疗中的应用。如今AI已广泛融人类入日常生活，未来它将如何影响乳腺癌患者的治疗仍未知，为此，会议特别设置了教育环节，探讨AI的实际影响，并有多场口头报告研究介绍AI作为早期乳腺癌预后和预测模型的应用。此外，AI还将融入临床病例讨论和辩论等环节。Virginia Kaklamani教授表示，专家与AI软件的互动以及AI可能带来的观念转变令人期待。 同时，今年会议还设置了关于早期乳腺癌患者是否都需要腋窝分期的辩论环节，以及众多展示乳腺癌研究与治疗最新进展的其他分会场。 成果丰硕：会议论文摘要数量创新高，多项奖项名单公布 Virginia Kaklamani教授指出，今年是乳腺癌研究领域成果丰硕的一年，全年呈现了多项关键试验，提交至SABCS的摘要数量也创历史新高，仅今年会议就将展示超过2200篇摘要。 本届会议还设置多项重要奖项，以表彰在乳腺癌研究与临床实践中做出突出贡献的科学家。其中，Armando Giuliano博士荣获William L. McGuire Award纪念讲座奖，以表彰其在早期乳腺癌腋窝手术方面的开创性工作。Ben HO Park博士和Sarah Tolaney博士分别获得美国癌症研究协会（AACR）颁发的乳腺癌研究杰出讲座奖和杰出研究者奖。 此外，为鼓励年轻科研人员，今年还评选出两位“新星奖”获得者，两位青年科学家——Frederick Howard博士与Nolan Priedigkeit博士荣获此奖项。 学术盛宴：特邀讲座与特色活动 据Virginia Kaklamani教授介绍，本次会议安排了两场全体大会讲座。第一场由Joan Brugge教授主讲，探讨BRCA1/2肿瘤发生的遗传和表观遗传决定因素；第二场讲座形式独特，由Debra A. Patt教授、Dennis J.Slamon教授和Barbara Segarra-Vazquez教授共同主讲，聚焦患者倡导在乳腺癌研究与治疗中的作用，强调患者倡导如何改变乳腺癌患者的治疗方式以及改变人们对乳腺癌研究的认知。 此外，Virginia Kaklamani教授表示，SABCS一直致力于支持年轻科学家，通过设立多个旅行奖，为年轻科研人员提供参会机会，使其接触乳腺癌研究与治疗前沿。今年将延续去年的“鸭子抽奖”活动，目前已售出超过700只鸭子，所得收益将用于年轻研究者旅行资助。去年共颁发20项旅行资助，今年有望进一步增加。当地时间12月11日（周四）将公布抽奖获奖者，同时设有10个奖项，敬请期待。Virginia Kaklamani教授还透露，会议周边商店的收益也将用于旅行资助和年轻研究者支持，今年吉祥物“Bruno the Bull”大受欢迎，几乎售罄。 深度剖析：乳腺癌治疗进展与挑战 随后，会议联合主席、美国德克萨斯大学西南医学中心Carlos Arteaga教授代表AACR发表开幕致辞。Carlos Arteaga指出，过去多年，乳腺癌的死亡率持续下降，这得益于筛查乳腺钼靶的普及、乳腺癌亚型的研究发现及其靶向治疗的发展、早期将转移性乳腺癌有效的药物和联合方案用于可手术的早期乳腺癌患者作为新辅助治疗，以及确立新的乳腺癌手术和放疗标准并推动FDA药物批准的临床试验。 然而，乳腺癌健康差异问题仍需关注。高影响力新药注册试验中，黑人和西班牙裔患者的入组率低于其他种族和族裔群体，这是未来需要改进的方向。过去几年，乳腺癌领域取得了多项药物批准成果，如Imlunestrant、Inavolisib和Dato-DXd等，这些成果离不开科研人员的努力。Arteaga教授还提到，NIH（美国国立卫生研究院）的资助面临挑战，其资助增长相对平缓，调整通胀后甚至呈下降趋势。AACR一直在努力推动增加资助，最近的民意调查显示，89%的选民支持联邦对NIH的资助。目前，美国国会正在提议增加NIH和NCI（美国国家癌症研究所）2026财年的资助，与政府提出的40%削减形成对比。最后，Carlos Arteaga教授呼吁乳腺癌社区发出声音，影响资助政策。 两位专家致辞结束后，现场对本届会议获奖者进行了表彰。此次开幕式为第48届SABCS会议奠定了坚实基础，未来三天，与会者将围绕乳腺癌研究与治疗的各个方面展开深入交流与探讨，共同推动该领域不断向前发展，为乳腺癌患者带来更多希望和福音。 （来源：《肿瘤瞭望-乳腺时讯》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。