NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
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Phase
—
Status
Completed
Study type
Observational
Enrollment
1,151actual
Sites
31
Countries
Argentina, Brazil, Dominican Republic +10
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-23 | actual | When the study began enrolling |
| Primary completion | 2025-05-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-19 | actual | The whole study's end, after follow-up |
| First posted | 2023-11-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HER2-negative
Primary outcomes
what the primary-completion date above is the date OFProportion of patients with IHC 1+ or IHC 2+/ISH- HER2 expression.
measured 6 months from the Last subject In
Proportion of patients with HER2 ultra-low (IHC 0 (pattern 0+) with membrane staining ie, incomplete and faint/barely perceptible in ≤10% tumor cells) HER2 expression and IHC null (IHC 0 ie, absent membrane staining),
measured 6 months from the Last subject In
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