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SHIELD: Surveillance of HR+/HER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC

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NCT07701070 · readout in 954 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Food and Drug Administration (FDA).

Phase
Status
Not yet recruiting
Study type
Observational
Enrollment
3,000estimated

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-09-30estimatedWhen the study began enrolling
Primary completion2029-03-30estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-03-30estimatedThe whole study's end, after follow-up
First posted2026-07-14actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-14actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Advanced Breast Cancer

Intervention

  • Other: Blood sampling

Primary outcomes

what the primary-completion date above is the date OF
Prevalence of ESR1 mutations in circulating tumour DNA
measured At baseline, approximately 3, 6, 9, 12, 15, and 18 months after initial testing
Emergence of ESR1 mutations during longitudinal ctDNA surveillance
measured At approximately 3, 6, 9, 12, 15, and 18 months after initial testing
Time to first detection of an ESR1 mutation
measured From first-line AI plus CDK4/6 inhibitor initiation to first ESR1 mutation detection

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