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
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Patritumab deruxtecan administered via IV infusion
Trastuzumab administered via IV infusion
Trastuzumab biosimilar administered via IV infusion
Pertuzumab administered via IV infusion
Tucatinib administered as oral tablets
Dana-Farber Cancer Institute ( Site 0050)
Boston, Massachusetts, United States
RECRUITINGRutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, United States
RECRUITINGPrisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville, South Carolina, United States
RECRUITINGInova Schar Cancer Institute ( Site 0051)
Fairfax, Virginia, United States
RECRUITINGKingston General Hospital ( Site 0061)
Kingston, Ontario, Canada
RECRUITINGPrincess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal ( Site 0004)
Montreal, Quebec, Canada
RECRUITINGJewish General Hospital ( Site 0003)
Montreal, Quebec, Canada
RECRUITINGRambam Health Care Campus ( Site 0011)
Haifa, Israel
RECRUITINGRabin Medical Center ( Site 0012)
Petah Tikva, Israel
RECRUITING...and 7 more locations
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented.
Time frame: Up to 21 days
Number of Participants with One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.
Time frame: Up to approximately 13 months
Number of Participants who Discontinue Study Intervention Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Time frame: Up to approximately 12 months
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)
Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC.
Time frame: At designated time points (up to ~13 months)
Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC
Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC.
Time frame: At designated time points (up to ~13 months)
Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC
Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC.
Time frame: At designated time points (up to ~13 months)
Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)
Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA.
Time frame: At designated time points (up to ~13 months)
Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA
Blood samples collected at designated time points will be used to determine the Ctrough of total patritumab deruxtecan ADA.
Time frame: At designated time points (up to ~13 months)
Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA
Blood samples collected at designated time points will be used to determine the AUC of total patritumab deruxtecan ADA.
Time frame: At designated time points (up to ~13 months)
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan free payload.
Time frame: At designated time points (up to ~13 months)
Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan free payload.
Time frame: At designated time points (up to ~13 months)
Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan free payload.
Time frame: At designated time points (up to ~13 months)
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