CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 217 enrolled
Drug / intervention
tucatinib +2 moredrug
Likely dose
tucatinib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04579380
NCT04579380Phase 2Active
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A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

Seagen, a wholly owned subsidiary of Pfizer·interventional·Posted Oct 8, 2020·Updated Dec 19, 2025

In Brief

A Phase 2 clinical trial evaluating tucatinib, trastuzumab, and 1 other intervention for Uterine Neoplasms and 5 related conditions. Active but no longer recruiting, targeting 217 participants across 106 sites in 8 countries.

Detailed Summary

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms
CountriesBelgium, Germany, Italy, Japan, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2ActiveOverdue
202120222023202420252026
First PostedOct 8, 2020
Enrollment StartJan 11, 2021
Primary CompletionNov 1, 2023
Study CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.7 years ago

Interventions

tucatinibdrug

300 mg orally twice daily

trastuzumabdrug

Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1

fulvestrantdrug

Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.