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Early\u2010phase oncology trials have conventionally relied on short\u2010term endpoints, such as overall response rate (ORR), to evaluate efficacy. However, there is a growing perception that incorporating longer\u2010term endpoints, such as progression\u2010free survival (PFS), into early\u2010phase dose\u2010finding trials can provide more informative guidance for dose optimization. This study proposes a new design, BOIN12\u2010PFS, to identify the optimal dose based on PFS, short\u2010term efficacy, and toxicity. As an extension of the BOIN12 design, BOIN12\u2010PFS is expected to be comparatively straightforward to implement in clinical oncology dose\u2010finding trials. Simulation studies demonstrate that the BOIN12\u2010PFS design offers advantages over existing designs in terms of the probability of selecting the OBD, the average number of patients allocated to the OBD, reducing overdosing, and requiring a smaller total sample size across various realistic settings.<\/jats:p>","DOI":"10.1002\/pst.70133","type":"journal-article","created":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:32:32Z","timestamp":1791246752000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["<scp>BOIN12<\/scp>\n                    \u2010\n                    <scp>PFS<\/scp>\n                    : A Bayesian Optimal Interval Phase\n                    <scp>I<\/scp>\n                    \/\n                    <scp>II<\/scp>\n                    Design Incorporating Progression\u2010Free Survival Endpoint"],"prefix":"10.1002","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-6082-8706","authenticated-orcid":false,"given":"Yusuke","family":"Tanaka","sequence":"first","affiliation":[{"name":"Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences Institute of Science Tokyo  Tokyo Japan"},{"name":"Quantitative Science and Evidence Generation Astellas Pharma Inc.  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