Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
217actual
Sites
106
Countries
Belgium, Germany, Italy +5
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 | 2021-01-11 | actual | When the study began enrolling |
| Primary completion | 2023-11-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2020-10-08 | actual | When this record first appeared on the registry |
| Results posted | 2024-11-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Uterine Neoplasms
- Uterine Cervical Neoplasms
- Biliary Tract Neoplasms
- Urologic Neoplasms
- Carcinoma, Non-Small-Cell Lung
- HER2 Mutations Breast Neoplasms
Interventions
- Drug: tucatinib — also filed as TUKYSA, ARRY-380, ONT-380
- Drug: trastuzumab — also filed as Herceptin
- Drug: fulvestrant — also filed as Faslodex
Primary outcome
what the primary-completion date above is the date OFConfirmed Objective Response Rate (cORR) as Assessed by Investigator
measured From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-24 · 1.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2021-10-06 · 618 KB · SAP_001.pdf
Publications
- PMID 39825152 — linked by the registry
- PMID 37751561 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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