OnCo
ideasIdea

Use residual disease tests to decide who needs ten years of hormone therapy

Many women take hormone-blocking tablets for a decade with real side-effects. A sensitive blood test could show who can safely stop at five years.

Extended adjuvant endocrine therapy prevents late recurrence in a minority while imposing joint pain, bone loss and sexual side-effects on everyone. Sensitive MRD testing at year five, repeated annually, could identify the persistently negative majority in whom continuation adds little, while intensifying treatment for the positive minority. This inverts the usual escalation-only use of MRD.

Hypothesis
Stopping endocrine therapy at five years in serially MRD-negative patients gives non-inferior distant recurrence-free survival at ten years, with materially better quality of life.
Rationale
Late recurrence in hormone-receptor-positive breast cancer arises from long-lived dormant cells, exactly the population a sensitive assay should detect. De-escalation guided by a negative test has already been accepted in principle for chemotherapy through genomic assays, so the regulatory and clinical logic is familiar.
What would test it
A registry-based non-inferiority randomisation at year five, with annual genome-wide MRD testing, patient-reported outcomes as co-primary, and pre-specified rescue for those who convert to positive.
Maturity
speculative
Who has to act
clinic
Cost to try
Medium ($1M to $50M)
Years to first evidence
7
Bottlenecks it attacks

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