drugset
drugset / Trial / NCT06797635

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635 ↗

Phase 2 Recruiting 372 enrolled Merck Sharp & Dohme LLC Daiichi Sankyo · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.

Timeline

Start
2025-03-20
Primary completion
2029-12-31
Completion
2034-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 1.5 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Patritumab deruxtecan Monoclonal antibody — Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Capecitabine Small molecule 1250 mg/m2 Oral
Background Olaparib Small molecule 300 mg Oral

Indications

breast cancer