This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Participants will receive a single dose of trastuzumab 600 mg SC separately, co-mixed or co-formulated with pertuzumab.
Participants will receive pertuzumab as a single agent injection, co-mixed or formulated as FDC with trastuzumab depending upon cohort. The dose will range from 400 to 1200 mg.
Auckland Clinical Studies
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Area Under the Concentration from Time Zero to Time Infinity (AUC0-inf) of Pertuzumab SC
Time frame: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)
Maximum Serum Concentration (Cmax) of Pertuzumab SC
Time frame: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)
Time to Reach Cmax (Tmax) of Pertuzumab SC
Time frame: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)
Minimum Serum Concentration (Cmin) of Pertuzumab SC
Time frame: Pre-dose (0 hours) and 6, 8, and 12 hours post-dose on Day 1; on Days 2, 3, 5, 8, 10, 15, 22, 43, 85; and at follow-up visit (up to approximately 24 months)
AUC0-inf of Pertuzumab IV
Time frame: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)
Cmax of Pertuzumab IV
Time frame: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)
Tmax of Pertuzumab IV
Time frame: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)
Cmin of Pertuzumab IV
Time frame: Pre-dose (0 hours) and 1.5 and 3 hours post-dose on Day 1; on Days 2, 3, 5, 8, 15, 22, 35, 43, 85; and at follow-up visit (up to approximately 24 months)
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 24 months
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Pertuzumab
Time frame: Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall)
Percentage of Participants with ATAs to Trastuzumab
Time frame: Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall)
Percentage of Participants with ATAs to rHuPH20
Time frame: Baseline, Day 22, Day 85, and 7 months post-dose (up to approximately 24 months overall)
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