# Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Source: https://onco.cc/trials/nct04579380/  
OnCo record `nct04579380` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Tucatinib, Trastuzumab and Fulvestrant in endometrial cancer, cervical cancer, biliary tract cancer and non-small-cell lung cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.

## Summary

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations is a phase 2 interventional study registered as NCT04579380 by Seagen, a wholly owned subsidiary of Pfizer, with 217 participants enrolled, started 2021-01-11 and due to reach its primary completion in 2023-11-01. Interventions recorded: tucatinib, trastuzumab and fulvestrant. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04579380
- Phase: 2
- Setting: 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
- Sponsor: Seagen, a wholly owned subsidiary of Pfizer
- Enrolled: 217
- Outcomes: Confirmed Objective Response Rate (cORR) as Assessed by Investigator: Tucatinib+Trastuzumab (Cohort 1) 27.3% vs Tucatinib+Trastuzumab (Cohort 2) 13.3% vs Tucatinib+Trastuzumab (Cohort 3) 46.7% vs Tucatinib+Trastuzumab (Cohort 4) 8% vs Tucatinib+Trastuzumab (Cohort 5) 8.3% vs Tucatinib+Trastuzumab (Cohort 6) 22.6% vs Tucatinib+Trastuzumab (Cohort 7) 0% vs Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) 41.9% vs Tucatinib+Trastuzumab (Cohort 9) 10.3%

## Sources

- ClinicalTrials.gov NCT04579380: https://clinicaltrials.gov/study/NCT04579380

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- key papers: [Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study](https://onco.cc/key-papers/paper-nct04579380-j-clin-oncol-2023/)

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