Clinical Trial

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.
Protocol Amendment History 7 changes
notable Trial sites expanded: 184 -> 192 locations 2026-07-11
notable Trial sites expanded: 171 -> 174 locations 2026-05-02
notable Trial sites expanded: 168 -> 171 locations 2026-04-24
notable Trial sites expanded: 163 -> 168 locations 2026-04-17
notable Trial sites expanded: 159 -> 163 locations 2026-04-14
notable Trial sites expanded: 154 -> 159 locations 2026-04-03
notable Trial sites expanded: 151 -> 154 locations 2026-03-27
Trial Details
NCT Number NCT07060807
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Breast Neoplasms
Enrollment 1,000 participants
Start Date 2025-07-21
Primary Completion 2033-07-14 (estimated)
Study Completion 2033-07-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-14