HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer
Merck Sharp & Dohme LLC
Summary
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
Description
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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 (HC…
Interventions
- BiologicalPatritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
- BiologicalTrastuzumab
Trastuzumab administered via IV infusion
- BiologicalTrastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
- BiologicalPertuzumab
Pertuzumab administered via IV infusion
- BiologicalTucatinib
Tucatinib administered as oral tablets
Locations (17)
- Dana-Farber Cancer Institute ( Site 0050)Boston, Massachusetts
- Rutgers Cancer Institute of New Jersey ( Site 0052)New Brunswick, New Jersey
- Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)Greenville, South Carolina
- Inova Schar Cancer Institute ( Site 0051)Fairfax, Virginia
- Kingston General Hospital ( Site 0061)Kingston, Ontario
- Princess Margaret Cancer Centre ( Site 0001)Toronto, Ontario