This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Multiple intravenous doses
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Nashville, Tennessee, United States
Pharmacokinetics: Area under the concentration-time curve
Time frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3
Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function
Time frame: approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Marseille, France
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
Unnamed facility
Catanzaro, Calabria, Italy
...and 3 more locations