Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
