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Phase I Trial Counselling — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsPhase I Trial CounsellingSCE Medical Oncology

A 50-year-old woman with metastatic breast cancer develops progressive disease on multiple lines of therapy. She is ECOG PS 1 and asks about phase I clinical trials. What is important to convey about phase I trial participation?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: A — Modern phase I oncology trials using molecularly-selected populations achieve objective response rates of approximately 20-30%, with some patients deriving meaningful clinical benefit alongside contributing to drug development

Modern phase I oncology trials have evolved significantly from the historical perception of 'last resort with no benefit'. Molecularly-selected phase I trials achieve ORR of approximately 20-30% (vs ~5% historically). Basket trials, expansion cohorts and precision medicine approaches have improved patient outcomes. Patient selection (good PS, adequate organ function) is critical. Participation also contributes to drug development and provides structured care. However, honest counselling about the primary objectives (dose-finding, safety) and possibility of no benefit is essential.

Reference: JRCPTB Medical Oncology Curriculum; Jardim et al Cancer 2017; ESMO Phase I Trial Guidelines