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
Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
At least 18 years-of-age at the time of signature of the informed consent form (ICF)
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Have a confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines immunohistochemistry 3+ (IHC3+) or fluorescence in situ hybridization + (FISH+))
Any systemic anti-cancer chemotherapy or small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drugs. At least 10 days must have elapsed between the last dose of such agent and the first dose of study drugs.
Prior treatment with anthracycline in any setting
Major surgery (excluding placement of vascular access) within 28 days of first dose of study drugs
Palliative radiation therapy within 14 days of first dose of study drugs
Single group
Tucatinib
DrugParticipants will receive tucatinib 300mg by mouth twice daily continuously (days 1-28) of each 28 day cycle.
Doxil
DrugParticipants will receive Doxil 40mg/m2 intravenously on day 1 of each 28 day cycle (with a maximum cumulative dose of 550mg/m2).
Objective response rate (ORR) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.
Proportion of participants with confirmed complete response (CR) or partial response (PR) to tucatinib in combination with Doxil according to RECIST v1.1 criteria.
Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) v5.0.
Incidence of treatment related adverse events (AEs) using CTCAE v5.0.
Progression-free survival (PFS) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.
Time from the first day of study drug administration (day 1) until disease progression as defined by RECIST v1.1, or death on study.
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