Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT04579380 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG fulvestrant
  • DRUG tucatinib
  • DRUG trastuzumab

Study Locations (20)

California

  • City of Hope at Huntington Beach — Huntington Beach
  • City of Hope at Irvine Sand Canyon — Irvine
  • Koman Family Outpatient Pavilion — La Jolla
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla
  • UC San Diego Moores Cancer Center- Investigational Drug Services — La Jolla
  • UC San Diego Moores Cancer Center — La Jolla
  • City of Hope at Long Beach Worsham — Long Beach
  • City of Hope at Long Beach Elm — Long Beach
  • City of Hope at Newport Beach Lido — Newport Beach
  • City of Hope Torrance — Torrance

Arizona

  • HonorHealth — Phoenix
  • HonorHealth — Tempe
  • The University of Arizona Cancer Center-North Campus — Tucson

Colorado

  • Rocky Mountain Cancer Centers — Aurora
  • Rocky Mountain Cancer Centers — Boulder
  • Rocky Mountain Cancer Centers — Thornton

Minnesota

  • Minnesota Oncology Hematology, PA — Coon Rapids
  • Metro Minnesota Community Oncology Research Consortium (MMCORC) — Saint Louis Park

Florida

  • Moffitt Cancer Center — Tampa

Missouri

  • Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices) — St Louis

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2021-01-11
Est. Completion 2026-04-30
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04579380

The ClinicalTrials.gov registry entry for NCT04579380 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 3 interventions — of which fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04579380 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04579380 about?

NCT04579380 is a clinical study titled "Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations". 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 (unresectab...

What is the current status of trial NCT04579380?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2021-01-11. Estimated completion is 2026-04-30.

What conditions does trial NCT04579380 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Uterine Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04579380?

The interventions under investigation include: fulvestrant (DRUG), tucatinib (DRUG), trastuzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04579380?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04579380 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial