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
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Time frame: Up to 21 days
Number of Participants with One or More Adverse Events (AEs)
Time frame: Up to approximately 13 months
Number of Participants who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 12 months
Secondary Endpoints
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)
Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC
Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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 * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention Arm 1: * Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting * Had disease progression on or after any previous trastuzumab deruxtecan (…
Read full criteria on CT.gov →✦ Analyst Commentary
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