The SURVIVE study: Re-evaluating follow-up in early breast cancer.

TPS658 Background: For decades, international guidelines unanimously recommended limiting routine follow-up in early breast cancer (EBC) to clinical exams and breast imaging, to detect potentially curable local relapse early. Additionally, guidelines explicitly advise against screening for distant recurrence in asymptomatic patients, as there remains no survival benefit in patients with earlier detected metastatic disease to date, at the cost of quality of life (1). However, as most of this data was published over 30 years ago, a re-evaluation of EBC follow-up strategies is urgently needed, considering numerous novel treatment options for both EBC and metastatic breast cancer patients. Methods: Study Design: The SURVIVE study is a prospective, multicenter, randomized controlled trial investigating a liquid-biopsy based follow-up in intermediate- to high-risk EBC patients. 3.500 EBC patients after completion of primary therapy (surgery, chemo- or radiotherapy) are randomized 1:1 to either standard or liquid-biopsy guided (intensified) follow-up. All patients receive guideline-based follow-up procedures. Additionally, blood samples are taken every 3 months (years 1–3), later every 6 months (years 4–5). While samples from patients in the standard-arm are biobanked, samples from the interventional arm are analyzed longitudinally for tumor markers (CA 27.29, CEA, CA 125, Tosoh Bioscience), CTCs (CellSearch, Menarini), and ctDNA (RaDaR, Neogenomics). The detection of abnormalities via liquid biopsy leads to staging examinations. For patients with confirmed recurrence, treatment hereafter follows national guidelines. The detection of true molecular relapse (positive liquid biopsy without clinical evidence of recurrence) leads to further monitoring within the SURVIVE protocol and creates the unique opportunity for treatment-intervention studies, such as SURVIVE HERoes (NCT06643585). Endpoints: The two co-primary endpoints are overall survival (OS) and the lead time, measured as the time from positive biomarker to positive imaging in the interventional arm. Secondary endpoints include breast cancer-specific survival, quality of life, and biomarker performance. Recruitment: As of January 2026, recruitment is active in 98 study centers in Germany. Currently, nearly 2,400 patients have been randomized since December 2022. Conclusion: The SURVIVE study is a long-anticipated study assessing whether intensified follow-up, guided by liquid biopsy, leads to earlier detection of recurrence and improved overall survival in EBC. NCT05658172. Funding: German Federal Ministry of Education and Research (BMBF), NeoGenomics, Menarini Silicon Biosystems, Tosoh Bioscience. Bibliography: Moschetti I, Cinquini M, Lambertini M, Levaggi A, Liberati A. Follow-up strategies for women treated for early breast cancer. Cochrane Database Syst Rev. 2016;CD001768. Clinical trial information: NCT05658172 .