RecruitingPhase 2NCT05748834

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

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer


Sponsor

SCRI Development Innovations, LLC

Enrollment

36 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of tucatinib (a targeted therapy) and liposomal doxorubicin (a chemotherapy) in patients with HER2-positive metastatic breast cancer — a subtype where cancer cells produce too much of the HER2 protein. Researchers want to see if this combination is safe and effective. **You may be eligible if...** - You are 18 or older - You have confirmed HER2-positive locally advanced or metastatic breast cancer - You have had at least 1 prior treatment with anti-HER2 therapy for advanced disease, or relapsed within 6 months of completing adjuvant HER2 therapy - You have at least one measurable tumor on scans - Your general health level is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have HER2-negative breast cancer - You have active or untreated brain metastases that are symptomatic - You have significant heart problems - You are pregnant or breastfeeding - Your liver or blood counts do not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTucatinib

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

DRUGDoxil

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


Locations(8)

Maryland Oncology Hematology

Columbia, Maryland, United States

Alliance Cancer Specialists

Bensalem, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology- DFW

Dallas, Texas, United States

Texas Oncology- San Antonio

San Antonio, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Care (Oncology & Hematology Assoc of SW Virginia, Inc)

Salem, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05748834


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