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
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
-
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 - 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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