A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
66actual
Sites
28
Countries
Japan, South Korea, Taiwan
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 | 2021-04-08 | actual | When the study began enrolling |
| Primary completion | 2023-07-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-01-25 | actual | When this record first appeared on the registry |
| Results posted | 2024-08-09 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Tucatinib — also filed as MK-7119, Tukysa
- Biological: Trastuzumab — also filed as Herceptin, Herceptin Hylecta
- Drug: Capecitabine — also filed as Xeloda
Primary outcome
what the primary-completion date above is the date OFConfirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants
measured From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-02-28 · 1.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-04-14 · 156 KB · SAP_001.pdf
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