About this trial
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment
Eligibility criteria
Qualifiers
Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Disqualifiers
Uncontrolled or significant cardiovascular disease
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
Has clinically severe respiratory compromise
Has any history of or evidence of any current leptomeningeal disease
Trial design
Treatments tested in this trial
- Patritumab deruxtecan
- Trastuzumab
- Trastuzumab Biosimilar
- Pertuzumab
- Tucatinib
Treatment groups
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Daiichi Sankyo
Collaborator