NCT06686394

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.

Conditions

• Breast Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Patritumab deruxtecan	Patritumab deruxtecan administered via IV infusion
BIOLOGICAL	Trastuzumab	Trastuzumab administered via IV infusion
BIOLOGICAL	Trastuzumab Biosimilar	Trastuzumab biosimilar administered via IV infusion
BIOLOGICAL	Pertuzumab	Pertuzumab administered via IV infusion
BIOLOGICAL	Tucatinib	Tucatinib administered as oral tablets

Timeline

• Start date: 2025-02-26
• Primary completion: 2030-04-18
• Completion: 2030-04-18
• First posted: 2024-11-13
• Last updated: 2026-02-13

Locations

17 sites across 6 countries: United States, Canada, Israel, Japan, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study