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

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Trial Identification

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

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

Study ID: NCT05748834

Conditions

Breast Cancer

Interventions

Tucatinib

Doxil

Study Description

Brief 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

Detailed Description: This is a Phase 2, open-label, single-arm study evaluating the combination of tucatinib with Doxil in participants with HER2+ breast cancer who have received at least one prior line of anti-HER2 therapy for locally advanced/metastatic disease or relapsed within 6 months of completion of anti-HER2 adjuvant therapy. This study will start with a lead-in phase wherein the first 6 patients will be evaluated weekly for one treatment cycle (28 days) to ensure the regimen is safe and tolerable. If no severe and/or unexpected toxicities are observed in these initial patients, the study will continue to enroll a total of 36 patients.