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

NCT04579380 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2025-12-19

Study results available
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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.

Conditions

  • Uterine Neoplasms
  • Uterine Cervical Neoplasms
  • Biliary Tract Neoplasms
  • Urologic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • HER2 Mutations Breast Neoplasms

Interventions

DRUG

tucatinib

300 mg orally twice daily

DRUG

trastuzumab

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

DRUG

fulvestrant

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.

Sponsors & Collaborators

  • Seagen, a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-11-01
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579380 on ClinicalTrials.gov