Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

NCT05748834 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-20

No results posted yet for this study

Summary

This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to:

* Learn how well the combination of tucatinib and Doxil works
* Learn more about the side effects of the combination of tucatinib and Doxil

Conditions

Interventions

DRUG

Tucatinib

Participants will receive tucatinib 300mg by mouth twice daily continuously (days 1-28) of each 28 day cycle.

DRUG

Doxil

Participants will receive Doxil 40mg/m2 intravenously on day 1 of each 28 day cycle (with a maximum cumulative dose of 550mg/m2).

Sponsors & Collaborators

  • Seagen Inc.

    collaborator INDUSTRY
  • Pfizer

    collaborator INDUSTRY
  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Erika Hamilton, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05748834 on ClinicalTrials.gov