A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
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.
Timeline
- Start
- 2025-07-21
- Primary completion
- 2033-07-14
- Completion
- 2033-07-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Patritumab deruxtecan | Monoclonal antibody | — | Intravenous |
| Comparator | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |