drugset / Trial / NCT07060807

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

NCT07060807

Phase 3 Recruiting 1000 enrolled Merck Sharp & Dohme LLC Daiichi Sankyo · collab
RandomizedParallel-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications