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Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

NCT04220203 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2025-06-26

No results posted yet for this study

Summary

The purpose of this program is to provide access to tucatinib in the United States before FDA approval.

Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle.

To learn more about this program, contact Seattle Genetics' Medical Information ([email protected]).

Conditions

Interventions

DRUG

Tucatinib

300 mg orally two times per day

DRUG

Capecitabine

1000 mg/m\^2 orally two times per day on Days 1-14 of each 21-day cycle

DRUG

Trastuzumab

Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Seagen, a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Diseases

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 NCT04220203 on ClinicalTrials.gov