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A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01513083
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: trastuzumab emtansine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Mild hepatic dysfunction Drug: trastuzumab emtansine
Multiple intravenous doses

Experimental: Moderate hepatic dysfunction Drug: trastuzumab emtansine
Multiple intravenous doses

Experimental: Normal hepatic function Drug: trastuzumab emtansine
Multiple intravenous doses

Primary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically documented invasive metastatic breast cancer
  • Human epidermal growth factor receptor 2 (HER2) -positive disease
  • Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Left ventricular ejection fraction >/=50%
  • Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)

Exclusion Criteria:

  • History of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
  • Investigational therapy or any other anticancer therapy </=28 days before first study treatment
  • Previous treatment with trastuzumab emtansine
  • Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
  • History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
  • Current peripheral neuropathy of Grade >/=2
  • Child-Pugh Class C hepatic impairment
  • Encephalopathy >/= Grade 2
  • For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
  • Active hepatitis A, B and/or C
  • Current unstable ventricular arrhythmia requiring treatment
  • History of symptomatic CHF (NYHA Classes II-IV)
  • History of myocardial infarction or unstable angina within 6 months of enrollment
  • History of a decrease in LVEF to<40% or symptomatic CHF with previous trastuzumab treatment
  • Pregnant or lactating women
  • Known HIV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01513083

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United States, Florida
Fort Myers, Florida, United States, 33905
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Oregon
Portland, Oregon, United States, 97239
United States, Tennessee
Nashville, Tennessee, United States, 37203
Canada, Ontario
Ottawa, Ontario, Canada, K1H8L6
Toronto, Ontario, Canada, M5G 2M9
Marseille, France, 13273
Paris, France, 75231
Toulouse, France, 31059
Catanzaro, Calabria, Italy, 88100
Udine, Friuli-Venezia Giulia, Italy, 33100
Barcelona, Spain, 08003
Madrid, Spain, 28007
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01513083     History of Changes
Other Study ID Numbers: BO25499
2011-004591-10 ( EudraCT Number )
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ado-trastuzumab emtansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action