The SURVIVE study: Liquid biopsy guided surveillance after intermediate- to high-risk early breast cancer.

• DOI: 10.1200/jco.2024.42.16_suppl.tps620
• Publication Date: 2024-05-29T16:38:29Z
• Authors: Kerstin Pfister; Sophia Huesmann; Thomas W. P. Friedl; Angelina Fink; Forca Mehmeti; Franziska Mergel; Henning Schäffler; Sabine Heublein; Andreas Daniel Ha...; Volkmar Mueller; Lisa Maria Wiesmu...; Tanja N. Fehm; Klaus Pantel; Brigitte Rack; Wolfgang Janni
• Keywords: Liquid biopsy

TPS620 Background: Current guidelines limit routine breast cancer (BC) follow-up to clinical examinations and imaging. This is based on the results of two large cohort studies conducted in 1980s that showed no improvement overall survival (OS) by an intensified screening for distant metastases. Thus, imaging metastases should currently only be performed patients with specific symptoms. To detect relapse a pre-symptomatic stage, we suggest evaluation liquid biopsy-guided surveillance, analyzing tumor markers (CA 27.29, CA 125 CEA), circulating cells (CTCs) DNA (ctDNA). Methods: Funded German Federal Ministry Education Research, SURVIVE study first large, randomized BC surveillance trial investigate potential benefit biopsy guided care intermediate- high-risk early patients. The multicenter, controlled phase 3 superiority study, which 3500 are 1:1 ratio standard vs. care. Eligible adults confirmed primary invasive intermediate BC, defined as indication (neo-)adjuvant chemotherapy, and/or size (> 50 mm), positive lymph nodes (≥ pN1mi), high grade G3). Primary anti-tumor therapy (surgery, adjuvant chemo- or radiotherapy) must have been completed previously. Patient enrollment during endocrine, antibody- targeted allowed. total duration 144 months. Stratification factors site well HR-, HER2- nodal status at surgery.Both arms receive according national guidelines, arm will tested markers, CTCs ctDNA via tumor-informed approach (RaDaR assay). Pre-specified abnormal findings any indicative minimal residual disease trigger complete staging. In event recurrence, guideline-based treatment follows, otherwise, testing continues. If applicable, participants may enter interventional trials. Statistics:The objectives determine whether intensified, leads better OS lead-time effect, compared surveillance. analyzed ITT population using Kaplan Meier methods cox regression models, lead time effect purely descriptive composite measure. Secondary include IDFS, DDFS, DRFS, BCSS quality life (QoL). Aims: We propose method, sensitivity specificity earlier detection (oligo-)metastases, enable initiation therapy. Clinical information: NCT05658172 .