Spots Global Cancer Trial Database for A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
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Trial Identification
Brief Title: A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Official Title: A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Study ID: NCT01513083
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Fort Myers, Florida, United States
, Detroit, Michigan, United States
, Portland, Oregon, United States
, Nashville, Tennessee, United States
, Ottawa, Ontario, Canada
, Toronto, Ontario, Canada
, Marseille, , France
, Paris, , France
, Toulouse, , France
, Catanzaro, Calabria, Italy
, Udine, Friuli-Venezia Giulia, Italy
, Barcelona, , Spain
, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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