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

NCT ID: NCT01513083

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild hepatic dysfunction

Group Type EXPERIMENTAL

trastuzumab emtansine

Intervention Type DRUG

Multiple intravenous doses

Moderate hepatic dysfunction

Group Type EXPERIMENTAL

trastuzumab emtansine

Intervention Type DRUG

Multiple intravenous doses

Normal hepatic function

Group Type EXPERIMENTAL

trastuzumab emtansine

Intervention Type DRUG

Multiple intravenous doses

Interventions

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trastuzumab emtansine

Multiple intravenous doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Fort Myers, Florida, United States

Site Status

Detroit, Michigan, United States

Site Status

Portland, Oregon, United States

Site Status

Nashville, Tennessee, United States

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Marseille, , France

Site Status

Paris, , France

Site Status

Toulouse, , France

Site Status

Catanzaro, Calabria, Italy

Site Status

Udine, Friuli Venezia Giulia, Italy

Site Status

Barcelona, Barcelona, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Countries

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United States Canada France Italy Spain

Other Identifiers

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2011-004591-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO25499

Identifier Type: -

Identifier Source: org_study_id