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)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Eligibility criteria

Qualifiers

Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer

Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)

Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation

Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Disqualifiers

Uncontrolled or significant cardiovascular disease

History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease

Has clinically severe respiratory compromise

Has any history of or evidence of any current leptomeningeal disease

Trial design

Treatments tested in this trial

  • Patritumab deruxtecan
  • Trastuzumab
  • Trastuzumab Biosimilar
  • Pertuzumab
  • Tucatinib

Treatment groups

81 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator